A Clinical-biological Prospective Cohort of Patients With BRAFV600E-mutated Metastatic Colorectal Cancer
Recruiting now · Not applicable
Conditions studied: Metastatic Colorectal Cancer, BRAF V600E Mutation Positive
In brief
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.
Key facts
- Study ID
- NCT05639413
- Run by
- UNICANCER
- People needed
- 400
- Starts
- 2023-07-24
- Expected to finish
- 2028-07-01
- Last updated by the study team
- 2025-12-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Men and women aged 18 years or older
- 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)
- Available tumor tissue sample obtained before inclusion with sufficient tissue left for biological studies. Patients with only fine-needle aspirations are not eligible.
- Known MMR/microsatellite status (immunohistochemistry [IHC] and polymerase chain reaction [PCR]) (or under analysis)
- 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 related to the investigator or the sponsor, can confirm in writing the patient's consent.
- Patients must be willing and able to comply with the study procedures
- The patient must be affiliated to a social security system or benefit of such a system.
You may not qualify if…
- Patient with another cancer concomitantly with the mCRC requiring treatment or influencing the prognosis according to the medical staff.
- Patients for whom the follow-up will not be assured by the investigator or its team.
- Any condition that may jeopardize patient participation in the study as well as non-contraception for men and women with child-bearing potential, and pregnancy or breast feeding for women.
- Persons deprived of their liberty or under protective custody or guardianship.
Where it is running
- Centre d'Oncologie Saint Yves — Vannes, France (enrolling)
- Centre Hospitalier de Bayeux — Bayeux, France (enrolling)
- Centre Leon Berard — Lyon, France (enrolling)
- Intitut Paoli Calmettes — Marseille, France (enrolling)
- Centre Antoine Lacassagne — Nice, France (enrolling)
- Aphp - Hopital Saint Louis — Paris, France (enrolling)
- Hopital Saint Antoine — Paris, France (enrolling)
- Aphp - Hopital Bichat — Paris, France (enrolling)
- Aphp - La Pitie Salpetriere — Paris, France (enrolling)
- Institut Mutualiste Montsouris — Paris, France (enrolling)
- Gh Diaconesses Croix Saint Simon — Paris, France (enrolling)
- Hopital Europeen Georges Pompidou — Paris, France (enrolling)
- Ch Perpignan — Perpignan, France (enrolling)
- Chu Poitiers — Poitiers, France (enrolling)
- Chu de Reims — Reims, France (enrolling)
- Chu Rennes Pontchaillou — Rennes, France (enrolling)
- Chu de Rouen — Rouen, France (enrolling)
- Centre Paul Strauss — Strasbourg, France (enrolling)
- Chu de Tours — Tours, France (enrolling)
- Chru de Nancy — Vandœuvre-lès-Nancy, France (enrolling)
- Institut Bergonie — Bordeaux, France (enrolling)
- Ch de Cahors — Cahors, France (enrolling)
- Chu Estaing de Clermont-Ferrand — Clermont-Ferrand, France (enrolling)
- GHPSO — Creil, France (enrolling)
- Aphp - Hopital Henri Mondor — Créteil, France (enrolling)
Full record on ClinicalTrials.gov
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