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Brief Title: A Clinical-biological Prospective Cohort of Patients With BRAFV600E-mutated Metastatic Colorectal Cancer
Official Title: A Study to Collect Patients, Medical, and Biological Data From Patients Being Treated for Metastatic Colorectal Cancer With a Specific Genetic Mutation: BRAFV600E
Study ID: NCT05639413
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.
Detailed Description: Despite substantial progress made in the first- and second line mCRC settings, there are still unmet clinical needs for patients harboring BRAFV600E mutations, especially those with microsatellite stability (MSS) / proficient mismatch repair (pMMR) tumor. The overall survival and access to different treatment in the real-life setting are unknown. Moreover, patient prognosis remains poor and therapeutic resistance to combinations with BRAF inhibitors, is at present, nearly universal. Therefore, it seems essential to prospectively collect clinical and biological data about this rare mCRC subtype. These data will allow us to improve knowledge and to identify clinical and biological factors that could drive therapeutic decisions, predict resistance to treatments, and that are prognostic for survival. In this context, we designed this large, prospective, cohort study 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 BRAFV600E mCRC. This collection of clinical and biological data (tumor tissue and blood samples) will allow us to identify predictive and prognostic biomarkers with several research work packages planned: i. To evaluate the circulating tumor DNA (ctDNA) during the metastatic first-, second-, and third-line treatment to: * Evaluate its positive and negative predictive value. * Identify molecular alterations preceding and explaining clinical resistance during BRAF/EGFR inhibition therapy and immunotherapy. ii. To evaluate BRAFV600E mCRC immune environment both at the tumor and blood level (immunomonitoring). iii. To study specific the dMMR/MSI BRAFV600E subgroup. Furthermore, the data collected will describe the therapeutic management of BRAFV600E mCRC patients in the routine-practice setting which will bring very useful data. The results of the COBRAF study could lay the groundwork to better understand BRAFV600E mCRC and to identify prognostic and predictive biomarkers helping the development of new therapeutic approaches in this population.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Centre Hospitalier D'Avignon, Avignon, , France
Centre Hospitalier de Bayeux, Bayeux, , France
Institut Bergonie, Bordeaux, , France
Ch de Cahors, Cahors, , France
Infirmerie Protestante de Lyon, Caluire-et-Cuire, , France
Chu Estaing de Clermont-Ferrand, Clermont-Ferrand, , France
Aphp - Hopital Henri Mondor, Créteil, , France
Groupe Hospitalier Mutualiste de Grenoble, Grenoble, , France
Chu de Grenoble Alpes - Hopital Michallon, La Tronche, , 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
Intitut Paoli Calmettes, Marseille, , France
Grand Hopital de L'Est Francilien - Site de Meaux, Meaux, , France
Centre Antoine Lacassagne, Nice, , 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
Ch Perpignan, Perpignan, , France
Chu Poitiers, Poitiers, , France
Chu de Reims, Reims, , France
Chu Rennes Pontchaillou, Rennes, , France
Chu de Rouen, Rouen, , France
Ch de Saint Malo, Saint-Malo, , France
ICANS, Strasbourg, , France
Chu de Tours, Tours, , France
Chru de Nancy, Vandœuvre-lès-Nancy, , France
Name: Christelle DE LA FOUCHARDIERE, MD
Affiliation: CENTRE LEON BERARD - LYON
Role: PRINCIPAL_INVESTIGATOR