RecruitingNot ApplicableNCT05639413
A Clinical-biological Prospective Cohort of Patients With BRAFV600E-mutated Metastatic Colorectal Cancer
A Study to Collect Patients, Medical, and Biological Data From Patients Being Treated for Metastatic Colorectal Cancer With a Specific Genetic Mutation: BRAFV600E
Sponsor
UNICANCER
Enrollment
400 participants
Start Date
Jul 24, 2023
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria7
- 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 Criteria4
- 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.
Interventions
OTHERCollection of blood samples
A 30 mL blood samples (6 mL in each of 5 EDTA tubes) will be collected from each patient at each timepoint.
Locations(45)
View Full Details on ClinicalTrials.gov
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NCT05639413
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