Terrain-Based Holistic Integrative Nutritional Metabolic Oncology

FEATURING

My YouTube Channel

Need Expert Professional Answers on RGCC Topics?

Dr. Donato has a Question & Answer Session in the YouTube Channel, AskDrMiven. The topics covers RGCC testing and interpretation. Dr. Donato will take questions sent to AskDrMiven@pm.me. The video podcast is meant for public education and not a diagnosis and treatment advice. Subscribers are welcomed to the channel.

Need Expert Professional Answers on RGCC Topics?

You can connect with Dr. Donato in Minnect, a mobile app that enables you to get professional answers quickly.

There are three options for engagement: 1) Send a text message and quickly get a text response. A text message can include RGCC testing or interpretation of a test result or a cancer question as it pertains to holistic and/or integrative therapy approaches. 2) For a more unique answer to your question, Dr. Donato can also send a personal video response. 3) For in-depth questions, you can book a video call.

To use the Minnect app, go to the App Store in your mobile device and download Minnect or Click Here. Create a User Account by clicking the "Sign Up" button below the "Login" button on the Login Screen. Login if you already have an account.

When you have logged in the Minnect app, in the question box at the top where it prompts "Find an expert...", enter my first name "Miven" or last name "Donato". This will take you to the page where you can connect with me. You can also navigate at the bottom of the app to "Chats" or "Calls".

About the Doctor

Background

Dr. Miven Donato graduated from Palmer College of Chiropractic in Davenport, Iowa (2001) with a Doctor of Chiropractic (DC) degree. He also has a Doctor of Physical Therapy (DPT) degree from Creighton University in Omaha, Nebraska (2009). His undergraduate degrees include a BSc in Physical Therapy from Loma Linda University (1990) and BSc in Medical Technology/Clinical Laboratory Science from Union College/Florida Hospital (1987). His solo practice in 2001 started with emphasis in orthopedic and sports therapy including dietary, health fitness and lifestyle medicine.

In 2010, Dr. Donato began to focus his practice in nutritional therapy. In 2012, he completed certification as a Gerson Practitioner at the Gerson Institute. Soon after he became an instructor for the Gerson Practitioner Training Program and was instrumental in starting the new distance-based online program in 2015. By 2018, he narrowed his scope of professional specialization to holistic integrative nutritional metabolic oncology care using the RGCC system of case management.

2018 was also the year Dr. Donato was introduced by a professional colleague to RGCC (Research Genetic Cancer Centre) testing. The blood test, also known as the "Greece Test" is a "liquid biopsy" that includes circulating tumor cell (CTC) detection and enumeration, identification of phenotype biomarkers for associated tissue source, behavioral risks (resistance/recurrence/metastasis), and chemosensitivity testing of cytotoxic agents and natural substances to enable creation of a personalized cancer therapy avoiding the guesswork.

To date, Dr. Donato has managed several thousand client cases in over 200 countries via live video meeting. He uses the RGCC system and believes that the layered application of principles from science in molecular oncology within an integrative therapeutic framework over a platform of whole foods plant-based diet and lifestyle medicine leads to higher positive clinical outcomes in cancer therapy.

Role

Dr. Donato takes the role of a professional health advocate or health coach providing the client or customer with informed choices in healthcare. The client or customer as a team member makes the final decision to follow a health path based on informed choices.

Dr. Donato helps to coordinate and integrate the client's choice and interfaces therapy tasks from various healthcare providers into one integrative cancer therapy protocol.

The role of the professional health coach does not replace the health advice or treatment prescription by a conventional healthcare provider or primary care medical doctor or medical specialist.

If help is needed for standard medical diagnosis and treatment, seek the advice of your medical healthcare provider.

Goal

To attain a level of consciousness that a healthy mind, body, and spirit is a balance that leads to a satisfying, happy, and joyful life, which is divinely inspired.

Aim

To reach the maximum positive clinical outcomes in therapy while maintaining an etiquette of practice that serves to satisfy societal expectations.

Live Video Meeting Appointment

Question & Answer Session (For New or Potential New Client)

Follow-Up Consult (For Established Client under Case Management)

Question & Answer Session (For New or Potential New Client)

This is a live online video meeting consultation with Dr. Donato who will answer general questions regarding Nutritional Metabolic Oncology Therapy, RGCC testing, and distance-based case management services. Click Here to book the 30-minute appointment (fee is shown in the link)

This appointment will help determine if you are a good candidate for onboarding case management with Dr. Donato.

New Client Initial Consult (For Onboarding Case Management)

Follow-Up Consult (For Established Client under Case Management)

Question & Answer Session (For New or Potential New Client)

This is a live online video meeting consultation with Dr. Donato to go onboard case management. Current clinical signs, symptoms, and health status will be reviewed along with blood labs, imaging, and pathology report. Discussion will include therapy strategies, expectations, and nutritional metabolic oncology therapy, Click Here to book the 1 hour appointment (fee is shown in the link).

If you have significant functional impairment and are not sure you are a good candidate to go onboard case management, please select the Question & Answer Session appointment first. You can also Click Here.

IMPORTANT!

After booking the New Client Initial Consult appointment Dr Donato LLC will assign a secure and encrypted portal to access a shared folder for upload and download of documents. Please follow the 5 Steps to Come Onboard as a Client for Case Management below.

Follow-Up Consult (For Established Client under Case Management)

This live online video meeting consultation with Dr. Donato is a routine Follow-Up Review for Established Clients under Case Management who missed a scheduled appointment and/or wish to reschedule the appointment. Click Here to book the appointment (fee is shown in the link).

IMPORTANT! This appointment spot is not for RGCC Test Interpretation service. For Interpretation Service, scroll down to RGCC Test Interpretation Service below and select the appropriate test or tests.

RGCC Test Order Consult (20-Minute Appointment)

Follow-Up Consult (For Established Client under Case Management)

This live online video meeting consultation with Dr. Donato is a service for anyone in the United States, Canada and United Kingdom interested in RGCC testing. There are many types of RGCC tests available. Dr. Donato will explain the purpose of each test and what test will be appropriate for your health condition. Click Here to book the 20-minute appointment (fee is shown in the link). Be sure you complete the RGCC Intake Form and send to DR Donato LLC. See below...

RGCC Test Price:

Click here to see the approximate test price. The actual price will differ slightly on the date of the test request.

IMPORTANT: After booking the appointment, Click Here to download and complete the RGCC Intake Form (the form is fillable in your computer or device) and then Click Here and go to Step 5 and follow the instructions on how to send securely to Dr Donato LLC.

Information from the RGCC Intake Form will be used to create an RGCC client account for Dr Donato LLC to order the test.

RGCC Follow-Up Consult (For Established Client under Case Management)

This live online video meeting consultation with Dr. Donato is a service for an Established Client under case management in the United States, Canada and United Kingdom for follow-up appointment

Click the appropriate link from the choices below associated with the follow-up test to book the 1 Hr follow-up appointment. Allow 4 weeks in advance when selecting the date for the follow-up appointment (fee is shown in the selected link below).

Click Here for OncoTrace test follow-up appointment

Click Here for OncoTrail test follow-up appointment

Click Here for Onconomics Plus follow-up appointment

Click Here for Onconomics Extracts+ test follow-up appointment

RGCC Test Price:

The actual test price varies by a few dollars from day to day due to changes in exchange rates from Euro to USD. The USD test price includes the test kit. Click Here to see the approximate test price. The actual price will differ slightly on the date of the test request.

Question & Answer Session (For Established Client under Case Management)

This is a live online video meeting consultation with Dr. Donato for an Established Client who has questions about the assigned therapy protocol following the New Client Initial Consult or for any questions (fee is shown in the selected links below).

Click Here to book a 15-minute appointment.

Click Here to book a 30-minute appointment.

RGCC Test Interpretation Service

Routine Blood Lab Test Interpretation Service (For Established or Non-Established Clients)

This is a live online video meeting consultation with Dr. Donato for RGCC Test Analysis, Detailed Interpretation and Explanation with commentary on PAST or CURRENT test results. This service is intended for a person who is an established client of an outside RGCC Practitioner but does not fully understand the test results and how the results are applied.

Select the specific RGCC test interpretation to book a consultation (fee is shown in the selected link below):

OncoTrace or OncoTrail Test: Click Here

Onconomics Extracts Test: Click Here

Onconomics Extracts+ Test: Click Here

Onconomics Plus Test: Click Here

Combo OncoTrace or OncoTrail + Onconomics Plus Tests: Click Here

Combo OncoTrace or OncoTrail + Onconomics Extracts+ Tests: Click Here

After booking a consultation, Click Here and go to Step 5 and follow the instructions on how to send the RGCC test results securely to Dr Donato LLC.

Routine Blood Lab Test Interpretation Service (For Established or Non-Established Clients)

This is a live online video meeting consultation with Dr. Donato for Routine Blood Lab Analysis, and Interpretation of CURRENT test results only. This service is intended for those who do not fully understand the routine blood test results.

Click Here to book a consultation (the fee is shown in the link).

After booking a consultation, Click Here and go to Step 5 and follow the instructions on how to send the blood test results securely to Dr Donato LLC.

What is the RGCC System in a Nutshell?

RGCC - Research Genetic Cancer Centre

RGCC International is a Swiss Biotech company with a global presence. Its headquarters is in Zug, Switzerland. RGCC combines research, development, clinical application & support, and adjunctive proprietary advanced therapeutics medicinal non-drug therapies for Oncology, Virology, and Lyme disease. For reference, please refer to the link for RGCC International and for RGCC International-North America.

RGCC Oncology

RGCC offers Liquid Biopsy testing for Oncology. A liquid biopsy is a non-invasive diagnostic study of cancer from a whole blood sample collected from a cancer client. A whole blood sample of about 25 mL can detect cancer cells at the earliest point in time even before signs and symptoms develop.

The cancer cells known as circulating tumor cells or CTCs released from tissue tumors are detected by Fluorescent Activated Cell Sorting (FACS) and multi-parameter antibody panel with flow cytometry. This enables enumeration, identification of CTCs by associated tissue sources, and subpopulation CSCs (cancer stem cells) that are associated with increased risk behaviors for resistance, recurrence and metastasis.

Harvesting the CTCs (including CSCs) from a whole blood sample enables 3D Culture & Sensitivity Testing of 150+ anticancer agents (chemo drugs, targeted drugs, off-label drugs, and natural anticancer supplements like Vitamin C) to determine what is most effective against the cancer cells in-vitro.

Running a molecular assay test known as Transcriptomic Microarray enables determination of the validated tumor related gene profile in order to select the appropriate anticancer agents proven in the 3D Culture & Sensitivity testing to block or inhibit the CTCs metabolic pathways and thereby decrease the cancer activity and reduce growth and proliferation.

Personalization of Cancer Therapy

Creating a personalized cancer therapy comes from selecting the highest efficacy or most effective anticancer agents (including radiotherapy and/or hyperthermia) without the guesswork.

A Cancer Therapy Strategy

Understanding the CTC concentration in blood, the behavioral risks, sensitivities and genetic profiles along with conventional blood labs, clinical imaging and tissue biopsy enables the creation of a comprehensive personalized cancer therapy strategy and plan of care blending conventional and holistic approaches for maximum positive therapeutic outcomes.

Please note:

The cancer therapy strategy outlined above is not intended to replace the standard conventional oncology case management but as an education to readers. Consult your oncologist for diagnosis and treatment of cancer.

TYPICAL CASE MANAGEMENT FLOW FOR ONBOARDED CLIENTS

INITIAL CONSULT

All initial consults will require results of recent routine blood tests, biopsy and/or surgical pathology and clinical imaging reports for review prior to the meeting. In this initial consult for onboarding case management, Dr Donato will discuss the details of personalized cancer therapy using the RGCC system. A baseline RGCC Oncotrace and Onconomics Plus blood tests is required in order to create the personalized cancer therapy. The personalized cancer therapy can be integrated with conventional oncology care that may have already started or about to start. A spreadsheet is used throughout the duration of personalized therapy to track the client's progress monitoring blood biomarkers for patterns in cancer behavior and correlated with clinical imaging for accurate assessment.

There are two scenarios to the Initial Consult:

In the first scenario, if RGCC baseline testing has already been completed and results analyzed and interpreted, Dr Donato will explain the personalized therapy protocol based on the RGCC test results.

In the second scenario, if RGCC baseline testing has not yet been done, a preliminary therapy protocol schedule is provided. Then Dr Donato will explain the baseline RGCC testing that will be arranged. If conventional cancer treatments have already started, there is a "pause period" of usually 14 days that is required prior to the RGCC blood draw. The "pause period" also applies to oral anticancer supplements and IV therapies.

To do the RGCC blood draw, a test kit containing a blood sample vial and a blood draw set is shipped to the client's address. The test kit will provide instructions to arrange for blood collection in the client's local area. Pre-filled paperwork for FedEx International shipping along with pre-paid shipping label is included in the kit. The blood sample is placed in the kit and shipped to the RGCC lab. Test results turn around time is approximately 14-16 days from the blood draw date.

Test results are analyzed and interpreted in a second meeting and the personalized therapy protocol is finalized.

In both scenarios described above, the client is provided with the necessary online sources to obtain the therapy agents that are in the protocol schedule.

The protocol schedule is followed by the client daily for the next 3 months. Instructions will be provided regarding the "pause period" from the therapy prior to the follow-up RGCC blood draw.

The period of time from the initial consult and scheduled follow-up review appointments, correspondence between client and Dr Donato will take place via emails, text messaging or video calls.

Established Clients will be able to sign up for individual secure portal to a shared folder for upload and download of information-sensitive files with Dr Donato LLC and to access resources such as RGCC supplement list, anticancer food photo examples, detox information, among many other services.

Follow-Up Review

A routine blood test and a follow-up RGCC blood test (Oncotrace or Oncotrail) will be required prior to a scheduled 4-month follow-up appointment. The follow-up consult will review the RGCC test results correlated with the routine blood tests along with any recent clinical imaging reports. The therapy protocol will be adjusted to address the changes based on the test results. And then client continues with the adjusted therapy protocol for another 3 months and the revolving process of retesting and adjustment of therapy protocol continues through the rest of the year.

Maintenance Therapy

When the desired therapy outcome goals have been achieved, the client is provided with a maintenance therapy protocol and a follow-up RGCC Oncotrace test for cancer surveillance is done once a year with a follow-up meeting and repeated for the next 4-5 years.

Dietary/Nutrition/Detoxification Education

Personalized dietary and nutrition, and detoxification instructions are provided at the initial consult and modified over time.

5 Steps to Come Onboard as a Client for Case Management

Step 1: Client Intake Form + Informed Consent Form

Download the pdf Intake Form and Informed Consent Form to your computer from the link below. Open the document in your computer. Turn on the Autofill feature in the pdf document and complete the form. Send the completed forms securely to Dr Donato LLC, see Step 5 below. Note: if your computer does not have a pdf Autofill feature, print the form out and complete by hand, take a photo of each page and send securely to Dr Donato LLC in Step 5 below.

Click here to download the Forms

Step 2: Biopsy and/or Surgical Pathology Report

You can provide the document after the meeting if it is not yet accessible

Step 3: Current routine blood test results

If you do not have current lab test results (less than 4 weeks) for the baseline and need to order blood tests, follow the instructions below on "Ordering Your Own Baseline Blood Tests" or if you wish for your healthcare insurance to cover this you can request your medical doctor to order the baseline lab tests listed.

Step 4: Latest imaging reports

Radiology reports from PET/CT, CT, MRI, NM Whole Body Bone Scan, Ultrasound, Mammogram, or plain x-rays, if any.

Step 5: Send the requested documents via assigned secure and encrypted shared folder with Dr Donato

IMPORTANT! Before sending the information-sensitive documents, please enable email encryption first on your end. Send to Dr Donato's secure email: drdonato@pm.me. For large files, please wait for Dr Donato LLC to assign you a secure portal to a shared folder with your name on it. You will then be able to upload or download files from the shared folder.

RECOMMENDATION: Sign up for a secure encrypted email account from Proton.Me, the same secure Swiss-based email service provider used by Dr Donato LLC. All future correspondence and attachments will be automatically end-to-end encrypted in Proton.Me users. Also, with a Proton.Me account, established clients will be assigned a secure and encrypted portal to a shared folder with Dr Donato LLC for access to resources, and meeting documents. Dr Donato will also be able to access client records within the same individual portal eliminating the need to attach documents via email.

INDIVIDUAL SECURE ENCRYPTED PORTAL:

A client who becomes established under case management will be assigned a portal access to a shared folder with Dr Donato LLC that is secure and encrypted. All documents sent by client to Dr Donato LLC or vice versa will be through the secure portal. To be an established client under case management, a one-time New Client Initial Consult (For Onboarding Case Management) is required. Click the above link or scroll up to Live Video Meeting Appointment.

PRIVACY OF INFORMATION

Please ONLY send the requested documents using encrypted email or through the assigned secure encrypted portal access to shared folders with Dr Donato LLC (for Established Clients under Case Management) in order to meet HIPAA requirements for privacy of information.

Ordering Your Own Routine Baseline Blood Tests

Baseline Lab Tests needed for Case Management

Comprehensive Wellness Profile (CWP): This bundled test consists of CBC with differential, Glucose, Electrolytes, Lipid Panel, Liver Panel, TSH, Kidney (metabolic panel), Mineral and Bone.

Inflammation Markers: CRP high sensitivity, ESR (sed rate), and Ferritin.

Vitamins: Vitamin B2 serum, Vitamin D 25 Hydroxy

Urinalysis, Complete with Microscopic Examination

Cancer Marker (below is a list of general cancer markers for biopsy-proven or established diagnosis of cancer ONLY and NOT for screening):

CA 27.29 or CA 15-3 (for Breast Cancer)

PSA (for Prostate Cancer)

CEA (for Colon Cancer or Lung Cancer)

CA 19-9 (for Pancreatic Cancer)

CA 125 (for Ovarian Cancer)

Thyroglobulin (for post-thyroidectomy Papillary Thyroid Cancer)

S100B (for metastatic Melanoma)

AFP (for Hepatocellular Liver Cancer)

Beta-2 Microglobulin (for Lymphoma or Leukemia)

CGA (for Neuroendocrine Cancer)

Direct Access Discounted Lab

Doctors Orders Not Necessary. Dr. Donato uses DirectLabs, a large client of Quest Diagnostics that provides discounted lab testing to the public. To order the above listed baseline lab tests, Click Here

DirectLabs services not available in NJ, NY, and RI

Quest services not available in AZ

Note: When ordering the routine lab tests at checkout, you have the option of instructing DirectLabs to send the test results to Dr. Donato besides automatically receiving yours. Enter the email address DrDonato@pm.me

Click here to order your own routine blood tests

Refunds & Cancellation Policies

Purchase Currency:

Currency accepted by Dr Donato LLC is ONLY in US dollar (USD)

Payment Forms

Dr Donato LLC accepts Stripe, Apple Pay, and Venmo. Apple Pay is only for iPhone users. Venmo is only available for US customers. PayPal is already an optional feature within Stripe.

Fees on services rendered by Dr Donato LLC

Services rendered by Dr Donato LLC are in the form of consulting via appointments made by clients or customers by their selection of services.

If the customer cancels the appointment or request prior to Dr Donato performing the service, a full refund of the service fee is issued back to the payment card within 5-10 business days. A full refund is also applied to an unintentional duplication of a service or services made by a client or customer.

Fees on RGCC Tests paid by client or customer directly to RGCC International North America

The cancellation of orders and refunds policy set by RGCC International will be processed as follows (done by RGCC International North America with notifications sent to Dr Donato LLC):

a. Cancellation Before Sample is Shipped: Refund issued at 100%.

b. Cancellation After Kit Has Been Drop-Shipped to Patient, Before Sample is Shipped to the Lab: 100 Euro kit fee will be deducted from the full price of the order or invoiced if order has not yet been placed.

c. Cancellation In Transit Before Arrival at the. Lab: 100 Euro kit fee will be deducted from the full price of the order. Cancellation Fee 100 Euro.

d. Cancellation Upon Arrival and/or In Response to "Incoming Samples" Email: Refund issued at 50%. Cancellation fee 50%.

e. Cancellation Between Confirmation of "Incoming Samples" Email and 24 Hours from Completion: Refund issued at 25%. Cancellation fee 75%.

f. Cancellation Within 24 Hours of Order Completion: No Refund. Cancellation fee 100%.

Note: Any dispute is settled between the client or customer and RGCC International North America.

Payments made through Online Store and DirectLabs

Client or Customer Cancellation & Refund Policies are as published by Fullscript and DirectLabs in their website domains. Note: Any dispute is settled between the client or customer and Fullscript or DirectLabs.

Contact Information:

Client or Customer may contact Dr Donato LLC by sending inquiries to: DrDonato@ pm.me

Frequently Asked Questions

Please reach us at drdonato@pm.me if you cannot find an answer to your question.

What is RGCC testing?

RGCC stands for Research Genetic Cancer Centre. It was founded by medical oncologist and genetics researcher, Dr. Ioannis Papasotiriou, MD, PhD in 2004. RGCC is an oncology research and development company that has 25+ branches in 20+ countries, and the global presence is increasing. RGCC headquarters is in Switzerland and general lab in Greece. There are other labs in Germany and India that are for research purposes.

RGCC testing is a molecular oncology blood test also known as “liquid biopsy” that detects whole cancer cells (circulating tumor cells) disseminated from primary and/or metastatic sites or from unknown primary sites at very low level, and enabling enumeration for the baseline, and for identification of the heterogeneous cancer cell population. The test is not meant to replace current conventional diagnostics, but like imaging and routine blood work it provides a more accurate assessment of the cancer status when combined with routine imaging study and routine blood labs.

An analogy comparing conventional diagnostics with RGCC testing is as follows. When doing clinical imaging studies (PET/CT, CT, MRI, US, Mammogram scans) of the body, on one hand it is like looking down at a forest from a drone high above and seeing the landscape and the borders or perimeters of an area of interest but unaware of what is happening at the ground level under the canopy of the trees. RGCC testing on the other hand is like looking from the roots of the trees up to the ground level to see what is happening. The view from the drone can spot changes in the topography, shape, borders, and perimeters of the forest indicating suspicious activity below, but a closer look down at the ground level and roots of the trees may reveal a different situation. Combining the two information produces an accurate assessment of the area of interest for baseline and future comparisons.

When making clinical decisions and creating therapy plans, an assessment or clinical impression of the disease condition needs to be as accurate as possible. Conventional oncology diagnostics have relied on technologies that have not matched the growing molecular oncology diagnostics until recent years. Around 2015, advances in molecular oncology diagnostics introduced “liquid biopsy”, which involves whole blood studies of circulating tumor DNA (ctDNA) from circulating tumor cells (CTC) and cell-free DNA (cfDNA) released by cells into the blood. Detecting ctDNA and cfDNA enables early cancer diagnosis for conventional oncology. The process of determining the targeted drug therapy is based on empirical data based on biopsy-proven cancer diagnosis, clinical trials and what the NCCN guidelines and FDA has approved for treatment of the cancer diagnosis.

Unlike detecting ctDNA and cfDNA, RGCC testing detects CTCs in the blood, identifies biomarkers that points to associated tissue of origin, risks (aggressive, resistance, recurrence, metastastasis) and 3D culture & sensitivity testing to determine the most effective therapeutic anti-cancer agents (drugs or natural supplements) against the cancer cells in-vitro. There is no need to guess what works when using RGCC testing. The testing further provides the information on CTC resistance factors and tumor related gene profile encoding the respective abnormally over-expressed metabolic pathways in order to block the cancer cells from growth, proliferation, or escape. Currently 150+ anti-cancer agents are tested routinely, and additional anti-cancer agents can be added to the blood sample for testing at the discretion of the practitioner.

Integrating and correlating RGCC testing data with conventional oncology diagnostics and application of conventional and/or holistic therapy enables maximum potential for positive clinical outcomes in oncology care.

Where is the headquarters of RGCC International?

RGCC International is in Zug, Switzerland

Is there a representative RGCC branch office in the US?

RGCC International North America

What tests are performed by RGCC?

Click Here to read about the various tests available.

What is the process of getting RGCC testing?

During the RGCC Test Order Consult Dr. Donato will initiate a request to RGCC North America distribution center in Atlanta, GA to drop ship a RGCC test kit to your home address (for North America residents only) via FedEx Ground. Delivery takes 4-8 days depending on location. The test kit contains a disposable blood draw kit, a vial containing EDTA to collect the blood sample, collection and shipping instructions and international paperwork (mostly pre-filled except your name, signature and date of blood draw), and a pre-paid FedEx International Priority shipping label. Blood draw service is either through AnyLabTestNow center (if available in your area) or via local mobile phlebotomy service. The test kit with the collected blood sample is taken to a local FedEx Store or hub to ship. Turn around time for test results averages 14-16 days. Results will be forwarded to you by Dr. Donato.

Click Here to view a video clip about the RGCC blood collection and shipping to the lab.

Is there any published research about RGCC testing?

Literature References for Validity, Precision,

Accuracy, and Methodology of RGCC Testing

Liquid Biopsy Review Articles

CTC Detection and Isolation:

A scientific study by RGCC scientists in 2015 reported on the challenges in the

detection and isolation of circulating tumor cells (CTCs). The study presented an

alternative fluidic-based method of isolating CTCs from many cancer types.

Basically, the alternative method is based on the detection of CTCs using blood

samples stained with antibodies to detect biomarkers while isolated and

enumerated by flow cytometer. The sensitivity or true positive data was 86.6%, and

the specificity or true negative data was 83.3%.

https://rgcc-international.com/wp-content/uploads/Osaka.Japan_.Circulating-Tumor-Cells-Challenges-in-Detection-and-Isolation.pdf

CTC Detection and Isolation using Negative Selection Method:

CTC detection is a rare event. This report describes the method for isolating

circulating tumor cells using a process of positive and negative selection method by

magnetophoresis, a magnetic field force used to separate CTCs from other cells and

other particles. It showed that CTC isolation and quantification using the negative

selection yielded a higher quantity of CTCs than the positive selection. RGCC

employs the negative selection method, while other competitors use the positive

selection method, relying only on EpCAM expression on a CTC but missing the

EpCAM negative CTCs.

1. https://www.intechopen.com/chapters/51880

2. https://www.akadeum.com/technology/positive-selection-vs-negative-selection/?cn-%20reloaded=1

3. https://karger.com/cpb/article/40/3-4/411/74763/Evaluation-of-Isolation-Methods-for-Circulating

CTC Detection in Breast Cancer Patients:

Circulating tumor cells (CTCs) are cancer cells disseminated from the primary tumor

into the bloodstream at very low numbers. The detection of CTCs from blood

sample is a form of liquid biopsy. The FDA-approved system is Cell Search, which

reveals only the enumeration and limited phenotype expression of 2 markers, CD45

and EpCAM, from the magnetic bead-based isolation method. RGCC, on the other

hand, employs flow cytometry with antibody staining with multiparameters in this

alternative fluidic based method. This method proved to be very sensitive to detect

CTCs.

https://rgcc-international.com/wp-content/uploads/JCT_2019082714362025.pdf

CTC Analysis as Diagnostic Tool for Chemotherapy Response:

Blood samples were collected from 57 cancer patients, and their CTCs were

enumerated and identified. The CTCs were also isolated and cultured, and diﬀerent

chemotherapeutic agents were added to determine chemosensitivity. In addition,

gene expression profiles of the CTC were determined by molecular-based assays via

qRT-PCR (quantitative reverse transcription polymerase chain reaction). The CTC

gene expression profiles oﬀered the ability to predict response to therapeutic agents

in addition to monitoring response to therapy or progression of disease.

https://rgcc-international.com/wp-content/uploads/Poster-RGCC-AACR-2018.pdf

CTCs to monitor disease progression and possible metastatic potential:

This report describes the use of multiparameter flow cytometric panel and magnetic

bead separation methods to enumerate and identify the CTCs from patients with and

without metastasis in cell cultures. It was found that CTCs from metastatic cancer

showed greater cell growth in CTC cultures, their count was higher compared to non-

metastatic cancer samples, and the expression of the tumor specific markers were

greater, which leads to an understanding of metastatic potential.

https://rgcc-international.com/wp-content/uploads/Poster-2018-lisbon.pdf

Prediction of Metastases through Study of CTCs:

The study here tested the CTC’s gene expression profile involved in metastasis to

organs. Blood samples from 35 cancer patients were enumerated, isolated,

phenotype identified, and subjected to cell culture and molecular-based assays. It

was found that the more advanced the disease, the higher the CTC number. The

higher the CTC number, the higher the expression of the markers. Some cancer

samples, like breast, prostate, and ovarian cancer, expressed markers to various

organs that correlate to their profile or repeatable pattern.

https://rgcc-international.com/wp-content/uploads/Risk-prediction-of-metastasis-through-study-of-circulating-tumor-cells.pdf

Review Article of Liquid Biopsy in Diagnosis and Prognosis of Colorectal Cancer:

This report discusses liquid biopsy principles at length, in particular, colorectal

cancer. Among the types of liquid biopsy discussed, include ctDNA (circulating

tumor DNA from CTCs), circulating free DNA (cfDNA) and CTCs as diagnostic and

prognostic indicators in colorectal cancer.

https://lupinepublishers.com/cancer-journal/pdf/OAJOM.MS.ID.000199.pdf

Chemosensitivity Assays using Liquid Biopsy of Melanoma CTCs:

This is a study reporting the utilization of CTC liquid biopsy for tumor information and

for predicting response to a chemotherapeutic agent from chemosensitivity assays. It

was found that the methodology provided feasible and valuable potential in its utility

in the case of the melanoma pilot study.

https://rgcc-international.com/wp-content/uploads/CTC-mel-BMC-2020.pdf

Predictive Potential of Chemosensitivity and Gene Expression Assays of CTCs from

patients with recurrent ovarian cancer(a pilot study):

This is a 2020 International Journal of Molecular Sciences report of a pilot study

using liquid biopsy and chemosensitivity assay from 10 cancer patients, 9 with stage

3C and 1 with stage 4 ovarian cancer. CTC chemosensitivity assay showed feasibility

and had the potential to predict response to therapy. The conclusion to the pilot

study showed that “the methodology for liquid biopsy, sample storage and transport,

CTC purification and transient in vitro culture, and subsequent chemosensitivity and

gene expression assays are both feasible and reproducible”.

https://rgcc-international.com/wp-content/uploads/International-Journal-of-Molecular-Sciences.pdf

Real-life Precision of Liquid Biopsy selecting drugs compared to Tissue Biopsy:

This 2020 report in the Journal of Cancer Research and Clinical Oncology about a

multidisciplinary treatment of unresectable colorectal liver metastases (CRCLM)

using liquid biopsy precision oncotherapy in selecting drugs in comparison to tissue

biopsy precision oncotherapy to 106 unresectable CRCLM patients. The study

conclusion reported that drug regimens selected by liquid biopsy precision

oncotherapy is safe and eﬃcacious alternative strategy and should be considered for

multicenter prospective phase III study to confirm the potential.

https://link.springer.com/content/pdf/10.1007/s00432-020-03156-3.pdf

Stemness Gene Profile of CTCs (transcription factors involved in turning on and oﬀ

cancer genes):

This 2017 report discusses the stemness transcription factors of the CTCs (Nanog,

OKT-4, CD34, Nestin, and Sox-2) in the initiation of metastasis. In the study, a subset

of CTCs known as CSCs are discussed and their gene signatures. Nanog, Sox-2 and

OKT-4 are overexpressed in CSCs (cancer stem cells). The expression of the stemness

transcription factors can be useful as prognostic indicators.

https://rgcc-international.com/wp-content/uploads/Stemness-Gene-Profiles-of-Circulating-Tumor-Cells.pdf

Gene expression profiling that supports the Onco-D-clare cancer screening test for

healthy subjects:

This is a 2019 report that showed isolation of peripheral blood mononuclear cells

(PBMCs) underwent gene expression clustering analysis using qRT-PCR assay on non-

cancer and cancer donors. Since CTCs (circulating tumor cells) are a sub-population

of PBMCs, the isolation of PBMCs and the analysis of their gene expression profile

performed for more than 50 genes using qRT-PCR and clustering analysis based on

algorithms (hierarchical and k-means) was able to successfully discriminate between

normal and cancer samples, as well as to discriminate diﬀerent types of cancer.

https://rgcc-international.com/wp-content/uploads/Oncotarget.pdf

Study showing contribution of WBC gene expression in prediction of cancer

(supporting the introductionof Onco-D-clare cancer screeningtestfor

healthysubjects):

This is a 2020 report about the study of white blood cells (WBCs) from whole blood

undergoing a total RNA extraction and qRT-PCR reaction of 50+ genes that are

known to be oncogenes, tumor suppressor genes, etc. and the outcome values were

applied to a supervised pattern recognition model, which was an artificial neural

network (AI) system. The average accuracy was 90.24%, achieving a high

identification ability to predict health or cancer presence. This forms the basis of the

new cancer screening test, Onco-D-clare for healthy subjects.

https://rgcc-international.com/wp-content/uploads/Binder1-abstract-1.pdf

Treatment based on Tumor Related Gene Expression:

Treatment of cancer cells based on Circulating Tumor Cell’s expression profile

using oﬀ-label drugs:

This study reported in October 2023 was performed on blood samples collected from

500 patients with diﬀerent types of cancer. CTCs were detected, isolated and their

biomarkers identified followed by gene and protein expression assays and compared

with a parallel literature research performed for the proteins and the respective

approved drugs. Based on the expression profile, the use of oﬀ-label drugs to specific

targets, and their chemosensitivity to CTCs were performed. The CTC overexpression

profile matched the already approved drugs in specific types of cancer, which led to

decrease CTC viability independent of cancer type in up to 25% of cases.

https://rgcc-international.com/wp-content/uploads/FPN553P-Poster-Apostolou-ESMO-Annual-2023.pdf

Gene Expression analysis in CTCs with Colorectal Cancer compared with

established protocols:

This study was reported in 2023 that showed CTC gene expression analysis compared

with established conventional protocols. While the study showed CTCs in almost all

cases showed sensitivity to radiotherapy and hyperthermia, the overexpressed genes

showed associated response to chemo drugs, although not all genes are upregulated

in all cases.

https://rgcc-international.com/wp-content/uploads/Poster-ESMO-GI-2023.pdf

Circulating Tumor Cell Gene Expression and Chemosensitivity predictive accuracy

for refractory recurrent rectal cancer:

This is a study released in 2022 showing the predictive accuracy for response to

treatment of unresectable refractory recurrent rectal cancer or colorectal liver mets.

The study employed CTC analysis by liquid biopsy and cultured in vitro and their gene

expression determined as a ratio to the gene expression of peripheral mononuclear

blood cells (PBMCs) to calculate the predictive accuracy. The evaluation showed the

overall calculated predictive accuracy was 47.22%. It is expected that further

development in technology and upgraded methodology will lead to improvement in

the predictive accuracy.

https://link.springer.com/epdf/10.1186/s12885-022-09770-3?sharing_token=VWH0gRy0G5eSslvukhPX5W_BpE1tBhCbnbw3BuzI2RMcH4E1QlfH

Sensitivity Testing of a Natural Substance:

This is a study reported in 2023 regarding the eﬀect of Astaxanthin in various human

cancer cell lines. Viability assays (sensitivity testing) using astaxanthin were

performed on breast cancer (hormone positive and triple negative), colon cancer,

lung cancer, and prostate cancer (hormone refractory and hormone sensitive). The

study showed astaxanthin aﬀected the proliferation of the cancer mentioned cancer

cell lines, likely due to modulating of signaling pathways involved in growth and

metastasis.

https://rgcc-international.com/wp-content/uploads/Poster-DGHO-Annual-2023.pdf

Susceptibility to Hyperthermia through CTC study:

Presentation document: This is a slide presentation of increased expression of Heat

Shock Protein, which correlated with resistance to hyperthermia.

https://rgcc-international.com/wp-content/uploads/ESHO_2019_Presentation.pdf

Abstract: The study of the CTC gene expression profile, specifically Heat Shock

Proteins (HSP) can be used to measure susceptibility to heat destruction

(hyperthermia).

https://rgcc-international.com/wp-content/uploads/Abstract-ESHO-Annual-2019.pdf

Cell Culturing Assays:

Comparison of Cell Culturing Assays: This study reported in 2019 compared 3

diﬀerent cytotoxic assays MTT (3-(4,5-dimethylthiazol- 2-yl)-2,5-diphenyl

tetrazolium bromide), SRB (sulforhodamine B) and CVE (crystal violet elution) for

linearity at diﬀerent cell densities. The assays are meant to pre-clinically evaluate the

activity of potential drug or substance. Each were discussed for linearity. CVE

demonstrated the most linear results at fixed time points while SRB gave the most

linear results especially between 9,000 to 12,000 cells. MTT showed the least linear

relation between optical density and cell number.

https://rgcc-international.com/wp-content/uploads/JCT_2019072315145979.pdf

Viability of Blood After Collection and Transportation:

Evaluation of blood sample storage and viability of CTCs: This study evaluated the

storage of blood samples that enabled isolation of CTCs 96 hours aŌer sample

collection. Blood samples were collected from healthy individuals and patients with

cancer. The samples were stored at 2-8 degrees C and analyzed aŌer 0, 24, 48, 72 and

96 hours of storage. Analysis was made by PCR and flow cytometry. Transportation of

blood at temperature between 2-3 degrees C in presence of EDTA anticoagulant can

protect CTCs from altered gene and protein expression for at least 72 hours. CTCs

can be detected and isolated even 96 hours after blood collection.

https://rgcc-international.com/wp-content/uploads/Apostolou-et-al.-J-of-Biol-Res-Thessaloniki-2017-24-11.pdf

Click Here to read more on RGCC research publication.

What does positive clinical outcomes mean?

There are 3 types of positive clinical outcomes:

1. Stability of disease. This means the disease has stopped progressing. The symptoms have not worsened and is manageable. A person can live a long time at this stage with continued therapy.

2. Partial improvement. This means the disease has reduced or a malignant tumor has shrunk but did not disappear. The symptoms have improved, and body functions may have almost normalized.

3. No evidence of disease. This means the disease is no longer detected by conventional diagnostic study. There are no symptoms. Body function is normal. In essence the disease is in remission.

Terrain-Based Holistic Integrative Nutritional Metabolic Oncology

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