A Clinical-biological Prospective Cohort of Patients With BRAFV600E-mutated Metastatic Colorectal Cancer
COBRAF
A Study to Collect Patients, Medical, and Biological Data From Patients Being Treated for Metastatic Colorectal Cancer With a Specific Genetic Mutation: BRAFV600E
2 other identifiers
interventional
400
1 country
45
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 gather real-world clinical data concerning the treatments and the survival outcomes in patients with this pathology.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2023
Longer than P75 for not_applicable
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 15, 2022
CompletedFirst Posted
Study publicly available on registry
December 6, 2022
CompletedStudy Start
First participant enrolled
July 24, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2028
December 10, 2025
December 1, 2025
3.9 years
November 15, 2022
December 9, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival (OS)
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.
From date of first diagnosis of mCRC and the date of death, whatever the cause, up to 5 years
Secondary Outcomes (8)
Collection of prospective data about BRAFV600E mCRC
Throughout study completion, up to 5 years
Correlation between prognostic markers and progression-free survival
From date of first diagnosis of mCRC and date of first progression or death, up to 5 years
Correlation between prognostic markers and overall survival
Throughout study completion, up to 5 years
Objective response rate
From baseline to first disease progression, up to 5 years
Disease control rate
From baseline to first disease progression, up to 5 years
- +3 more secondary outcomes
Study Arms (1)
COBRAF
OTHERA 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.
Interventions
A 30 mL blood samples (6 mL in each of 5 EDTA tubes) will be collected from each patient at each timepoint.
Eligibility Criteria
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)
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UNICANCERlead
- Pierre Fabre Medicamentcollaborator
Study Sites (45)
Centre Hospitalier D'Avignon
Avignon, 84000, France
Centre Hospitalier de Bayeux
Bayeux, 14400, France
Chu Simone Veil
Beauvais, France
Institut Bergonie
Bordeaux, 33076, France
CH Fleyriat
Bourg-en-Bresse, 01000, France
Ch de Cahors
Cahors, France
CH Dr TECHER
Calais, 62107, France
Infirmerie Protestante de Lyon
Caluire-et-Cuire, France
Chu Estaing de Clermont-Ferrand
Clermont-Ferrand, 63003, France
GHPSO
Creil, France
Aphp - Hopital Henri Mondor
Créteil, France
Groupe Hospitalier Mutualiste de Grenoble
Grenoble, 38028, France
Chu de Grenoble Alpes - Hopital Michallon
La Tronche, 38700, France
CH Louis Pasteur
Le Coudray, 28630, France
Groupe Hospitalier Emile Roux
Le Puy-en-Velay, France
Hopital Franco-Britannique
Levallois-Perret, 92300, France
Chu Dupuytren
Limoges, 87042, France
Centre Leon Berard
Lyon, 69008, France
Hôpital privé Jean Mermoz
Lyon, 69373, France
Hopital de La Timone
Marseille, France
Intitut Paoli Calmettes
Marseille, France
Grand Hopital de L'Est Francilien - Site de Meaux
Meaux, France
Centre Antoine Lacassagne
Nice, France
CHR d'Orléans
Orléans, 45100, France
Aphp - Hopital Saint Louis
Paris, 75010, France
Hopital Saint Antoine
Paris, 75012, France
Aphp - Hopital Bichat
Paris, 75013, France
Aphp - La Pitie Salpetriere
Paris, 75013, France
Institut Mutualiste Montsouris
Paris, 75014, France
Gh Diaconesses Croix Saint Simon
Paris, 75020, France
Hopital Europeen Georges Pompidou
Paris, France
Ch Perpignan
Perpignan, France
Chu Poitiers
Poitiers, 86021, France
Chu de Reims
Reims, 51100, France
Chu Rennes Pontchaillou
Rennes, 35000, France
Chu de Rouen
Rouen, 76031, France
Hôpital Privé de la Loire
Saint-Etienne, 42100, France
Hnia Begin
Saint-Mandé, France
Ch de Saint Malo
St-Malo, France
Centre Paul Strauss
Strasbourg, 67033, France
Hnia Saint Anne
Toulon, France
Chu de Tours
Tours, 37044, France
Chru de Nancy
Vandœuvre-lès-Nancy, 54500, France
Institut de Cancerologie de Lorraine
Vandœuvre-lès-Nancy, France
Centre d'Oncologie Saint Yves
Vannes, 56000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christelle DE LA FOUCHARDIERE, MD
CENTRE LEON BERARD - LYON
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 15, 2022
First Posted
December 6, 2022
Study Start
July 24, 2023
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
July 1, 2028
Last Updated
December 10, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Unicancer will consider access to study data upon written detailed request sent to Unicancer, from 6 months until 5 years after publication of summary data.
- Access Criteria
- The data shared will be limit to that required for independent mandated verification of the published results, the applicant will need authorization from Unicancer for personal access, and data will only be transferred after signing of a data access agreement.
Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.