Clinical trial · Interventional
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
NCT05639413CI-TRIAL-00098750COBRAFrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| BRAF V600E Mutation Positive | — | UNRESOLVED | — |
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Collection of blood samples | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- COBRAF
- description
- A 30 mL blood samples (6 mL in each of 5 EDTA tubes) will be collected from each patient at the following timepoints: * At the starts of cycle 1, 2 and 3, * At 3 and 6 months after starting of each treatment line, if applicable. * At disease progression after second-line treatment with encorafenib combined with cetuximab, if applicable. * At disease progression after immunotherapy-based treatment in dMMR/MSI patients. At most 390 mL of blood will be collected from each patient during the study.
- interventionNames
- Other: Collection of blood samples
Primary outcomes (1)
- measure
- Overall Survival (OS)
- timeFrame
- From date of first diagnosis of mCRC and the date of death, whatever the cause, up to 5 years
- description
- OS of patients with BRAFV600E mCRC in the real-life setting. The OS is defined as the time between the date of first diagnosis of mCRC and the date of death, whatever the cause. The patients alive at the time of analysis will be censored at the date of their last follow up.
Secondary outcomes (8)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 related to the investigator or the sponsor, can confirm in writing the patient's consent. 6. Patients must be willing and able to comply with the study procedures 7. The patient must be affiliated to a social security system or benefit of such a system. Exclusion Criteria: 1. Patient with another cancer concomitantly with the mCRC requiring treatment or influencing the prognosis according to the medical staff. 2. Patients for whom the follow-up will not be assured by the investigator or its team. 3. 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. 4. Persons deprived of their liberty or under protective custody or guardianship.
References
Publications (0)
Data not yet available
No reference posted for this study.