French Assessment of MRD by Liquid Biopsies in Colorectal With Liver Metastasis Patients (FRENCH.MRD.CRLM)
Recruiting · NCT06287723 · Observational (researchers observe without assigning treatment) · Lead sponsor: University Hospital, Montpellier
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.CRLM is the French study and part of the european GUIDE.MRD project.
Who can take part
Inclusion criteria
- Patient 18 years or older.
- Colorectal cancer liver metastasis or metastases, according to the assessment of the MDT.
- Metachronous and synchronous metastases will be included, as long as treatment intention of metastases resection is curative. In case of rare instances, where the liver metastases is removed before surgery of the primary tumor, postOP ctDNA is collected when the patient is considered completely tumor-free, i.e. after complete surgery of both the liver metastases and the primary tumor.
- Treatment is planned with curative intent (patients treated with RFA can be included, BUT in these cases a tissue sample from the primary CRC tumor is a requisite)
Exclusion criteria
- Hereditary colorectal cancer linked to familial colonic polyposis or Lynch syndrome.
- Extrahepatic metastases
- Malignant colorectal polyps diagnosed after polypectomy.
- 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.
- Liver cirrhosis
- CRLM intervention/surgery cannot be/was not performed with curative intent
- No tumor tissue available (preferably CRLM lesion, or alternatively primary tumor)
- 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.
Where it is running
2 locations listed.
- CHU de Montpellier - Montpellier, France
- Institu régional du Cancer de Montpellier (ICM) - Montpellier, France