Status:
RECRUITING
A Clinical-biological Prospective Cohort of Patients With BRAFV600E-mutated Metastatic Colorectal Cancer
Lead Sponsor:
UNICANCER
Collaborating Sponsors:
Pierre Fabre Medicament
Conditions:
Metastatic Colorectal Cancer
BRAF V600E Mutation Positive
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 gat...
Detailed Description
Despite substantial progress made in the first- and second line mCRC settings, there are still unmet clinical needs for patients harboring BRAFV600E mutations, especially those with microsatellite sta...
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Key Trial Info
Start Date :
July 24 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2028
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT05639413
Start Date
July 24 2023
End Date
July 1 2028
Last Update
December 10 2025
Active Locations (45)
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1
Centre Hospitalier D'Avignon
Avignon, France, 84000
2
Centre Hospitalier de Bayeux
Bayeux, France, 14400
3
Chu Simone Veil
Beauvais, France
4
Institut Bergonie
Bordeaux, France, 33076