A Clinical-biological Prospective Cohort of Patients With BRAFV600E-mutated Metastatic Colorectal Cancer
Recruiting · NCT05639413 · Interventional (participants receive a specific treatment) · Lead sponsor: UNICANCER
View the official record on ClinicalTrials.gov →Interventions studied
Collection of blood samples
What this trial is about
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 take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
45 locations listed.
- Centre Hospitalier D'Avignon - Avignon, France
- Centre Hospitalier de Bayeux - Bayeux, France
- Chu Simone Veil - Beauvais, France
- Institut Bergonie - Bordeaux, France
- CH Fleyriat - Bourg-en-Bresse, France
- Ch de Cahors - Cahors, France
- CH Dr TECHER - Calais, France
- Infirmerie Protestante de Lyon - Caluire-et-Cuire, France
- Chu Estaing de Clermont-Ferrand - Clermont-Ferrand, France
- GHPSO - Creil, France
- Aphp - Hopital Henri Mondor - Créteil, France
- Groupe Hospitalier Mutualiste de Grenoble - Grenoble, France
- Chu de Grenoble Alpes - Hopital Michallon - La Tronche, France
- CH Louis Pasteur - Le Coudray, France
- Groupe Hospitalier Emile Roux - Le Puy-en-Velay, France
- Hopital Franco-Britannique - Levallois-Perret, France
- Chu Dupuytren - Limoges, France
- Centre Leon Berard - Lyon, France
- Hôpital privé Jean Mermoz - Lyon, 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, France
- Aphp - Hopital Saint Louis - Paris, France
- Hopital Saint Antoine - Paris, France
- Aphp - Hopital Bichat - Paris, France
- Aphp - La Pitie Salpetriere - Paris, France
- Institut Mutualiste Montsouris - Paris, France
- Gh Diaconesses Croix Saint Simon - Paris, France
- Hopital Europeen Georges Pompidou - Paris, France
- Ch Perpignan - Perpignan, France
- Chu Poitiers - Poitiers, France
- Chu de Reims - Reims, France
- Chu Rennes Pontchaillou - Rennes, France
- Chu de Rouen - Rouen, France
- Hôpital Privé de la Loire - Saint-Etienne, France
- Hnia Begin - Saint-Mandé, France
- Ch de Saint Malo - St-Malo, France
- Centre Paul Strauss - Strasbourg, France
- Hnia Saint Anne - Toulon, France
- Chu de Tours - Tours, France
- Chru de Nancy - Vandœuvre-lès-Nancy, France
- Institut de Cancerologie de Lorraine - Vandœuvre-lès-Nancy, France
- Centre d'Oncologie Saint Yves - Vannes, France