French Assessment of MRD by Liquid Biopsies in Stage III CRC Patients (FRENCH.MRD.CRC)

Launched by UNIVERSITY HOSPITAL, MONTPELLIER · Feb 27, 2024

Keywords

ClinConnect Summary

The FRENCH Assessment of MRD by Liquid Biopsies in Stage III CRC Patients trial, also known as FRENCH.MRD.CRC, is a research study that aims to improve treatment for patients with stage III colorectal cancer. The study is exploring a new way to detect small amounts of cancer that may remain in the body after surgery by testing blood samples for circulating tumor DNA (ctDNA). This information could help doctors decide who might benefit from additional treatment after their surgery, ensuring that patients receive the right amount of care—no more, no less.

To participate in this trial, patients must be at least 18 years old and have colon or rectal cancer that is at stage I-III. They should be scheduled for surgery with the intention of curing the cancer. However, certain patients, such as those with hereditary cancer syndromes or other specific health conditions, may not be eligible. Participants can expect to provide blood samples and undergo monitoring to help researchers understand the best ways to use ctDNA testing in treatment decisions. This study is part of a larger European effort to standardize and improve cancer care for patients.

Gender

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Eligibility criteria

• • FRENCH.MRD.CRC PART I Inclusion criteria
• • Colon or rectal cancer, clinical tumor stage I-III.
• • Patient 18 years or older.
• • Scheduled for curative intent resection surgery (including "compromised" curative resections).
• • Exclusion criteria
• • Hereditary colorectal cancer linked to familial colonic polyposis or Lynch syndrome.
• • Verified distant metastases.
• • Malignant colorectal polyps diagnosed after polypectomy.
• • Patients who are unlikely to comply with the protocol (e.g. uncooperative attitude), inability to return for subsequent visits) and/or otherwise considered by the Investigator to be unlikely to complete the study.
• • Pregnant or nursing woman, or in childbearing age and not willing to use contraception
• • Protected and vulnerable adult
• • Not covered by Health insurance
• • Patient unable to understand and sign written informed consent.
• • FRENCH.MRD.CRC PART II Inclusion criteria
• • Participation in FRENCH.MRD.CRC part 1 - SURGERY
• • Colorectal cancer, UICC stage III
• • Has received curative-intent resection and is a candidate for adjuvant chemotherapy (3- or 6-months regime) Exclusion criteria
• • Inflammatory bowel disease (Crohn's disease or ulcerative colitis) related colon cancer
• • Not treated with adjuvant chemotherapy despite indication (incomplete treatment not included)
• • Treated with neoadjuvant chemo-radiation therapy
• • Synchronous colorectal and non-colorectal cancer diagnosed per operative (except skin cancer other than melanoma)
• • Other cancers (excluding colorectal cancer or skin cancer other than melanoma) within 3 years from eligibility screening
• • Patients who are unlikely to comply with the protocol (e.g. uncooperative attitude), inability to return for subsequent visits) and/or otherwise considered by the Investigator to be unlikely to complete the study