A Clinical-biological Prospective Cohort of Patients With BRAFV600E-mutated Metastatic Colorectal… (NCT05639413) | Clinical Trial Compass
RecruitingNot Applicable
A Clinical-biological Prospective Cohort of Patients With BRAFV600E-mutated Metastatic Colorectal Cancer
France400 participantsStarted 2023-07-24
Plain-language 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
Age range18 Years
SexALL
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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.
What they're measuring
1
Overall Survival (OS)
Timeframe: From date of first diagnosis of mCRC and the date of death, whatever the cause, up to 5 years