A Clinical-biological Prospective Cohort of Patients With BRAFV600E-mutated Metastatic Col
The study will be conducted in patients with metastatic colorectal cancer (mCRC) harboring a BRAFV600E mutation, to collect clinical data and biological samples to be used for research but also to gather real-world clinical data concerning the treatments and the survival outcomes in patients with this pathology.
| Condition(s) | Metastatic Colorectal Cancer, BRAF V600E Mutation Positive |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | The study will be conducted in patients with metastatic colorectal cancer (mCRC) harboring a BRAFV600E mutation, to collect clinical data and biological samples to be used for research but also to gather real-world clinical data concerning the treatments and the survival outcomes in patients with this pathology. |
| Who can participate | Inclusion Criteria: 1. Men and women aged 18 years or older 2. Histologically confirmed BRAFV600E metastatic colorectal cancer (mCRC), chemotherapy-naive in the metastatic setting or having initiated a first line of chemotherapy in the metastatic setting (except encorafenib-cetuximab treatment) 3. Available tumor tissue sample obtained before inclusion with sufficient tissue left for biological studies. Patients with only fine-needle aspirations are not eligible. 4. Known MMR/microsatellite status (immunohistochemistry \[IHC\] and polymerase chain reaction \[PCR\]) (or under analysis) 5. Patients must have signed a written informed consent form prior to any trial specific procedures. If the patients are physically unable to give their written consent, a trusted person of their choice, not |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | UNICANCER |
| Locations | Avignon, France; Bayeux, France; Beauvais, France; Bordeaux, France; Bourg-en-Bresse, France; Cahors, France (+39 more sites) |
| Start date | 2023-07-24 |
| NCT ID | NCT05639413 |
| Official listing | https://clinicaltrials.gov/study/NCT05639413 |