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

Summary

Improving personalized cancer treatments and finding the best strategies to treat each patient relies on using new diagnostic technologies. Currently, for colorectal cancer, the methods used to decide who gets additional post-surgery treatment are suboptimal. Some patients get too much treatment, while others do not get enough. There is a new way to explore if there is any cancer left in a patient's body using circulating tumor DNA (ctDNA) detected in blood samples. This can help decide who needs more treatment after surgery. Even though many tests have been developed, it has yet to be determined which test performs best at relevant time points. The GUIDE.MRD consortium is a group of experts, including scientists, technology, and pharmaceutical companies. The consortium is working on creating a reliable standard for the ctDNA tests, validating their clinical utility, and collecting data to help decide on the best treatment for each patient. FRENCH-MRD-CRC is the French study of the european GUIDE.MRD project.

Eligibility

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

Conditions5

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