Trial Title:
A Clinical-biological Prospective Cohort of Patients With BRAFV600E-mutated Metastatic Colorectal Cancer
NCT ID:
NCT05639413
Condition:
Metastatic Colorectal Cancer
BRAF V600E Mutation Positive
Conditions: Official terms:
Colorectal Neoplasms
Conditions: Keywords:
Clinical-biological cohort
Colorectal Cancer
BRAF mutation
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
The COBRAF study was designed as a prospective, multicenter, study. The study is without
a therapeutic intervention and is of minimal risk and constraints (category 2 according
to the "Loi Jardé"). The study will be conducted in patients with mCRC harboring a
BRAFV600E mutation.
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Collection of blood samples
Description:
A 30 mL blood samples (6 mL in each of 5 EDTA tubes) will be collected from each patient
at each timepoint.
Arm group label:
COBRAF
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centre Hospitalier D'Avignon
Address:
City:
Avignon
Zip:
84000
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Centre Hospitalier de Bayeux
Address:
City:
Bayeux
Zip:
14400
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Annie PEYTIER, MD
Email:
a.peytier@ch-ab.fr
Facility:
Name:
Institut Bergonie
Address:
City:
Bordeaux
Zip:
33076
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Ch de Cahors
Address:
City:
Cahors
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Slim LASSOUED, MD
Email:
slim.lassoued@ch-cahors.fr
Facility:
Name:
Infirmerie Protestante de Lyon
Address:
City:
Caluire-et-Cuire
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Chu Estaing de Clermont-Ferrand
Address:
City:
Clermont-Ferrand
Zip:
63003
Country:
France
Status:
Recruiting
Contact:
Last name:
Marine JARY, MD
Phone:
+33(0)4 73 75 05 08
Email:
mjary@chu-clermontferrand.fr
Facility:
Name:
Aphp - Hopital Henri Mondor
Address:
City:
Créteil
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Charlotte FENIOUX, MD
Email:
charlotte.fenioux@aphp.fr
Facility:
Name:
Groupe Hospitalier Mutualiste de Grenoble
Address:
City:
Grenoble
Zip:
38028
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Chu de Grenoble Alpes - Hopital Michallon
Address:
City:
La Tronche
Zip:
38700
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Victoire GRANGER, MD
Email:
v.granger@chu-grenoble.fr
Facility:
Name:
Groupe Hospitalier Emile Roux
Address:
City:
Le Puy-en-Velay
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Vanessa PANTE, MD
Email:
vanessa.pante@ch-lepuy.fr
Facility:
Name:
Hopital Franco-Britannique
Address:
City:
Levallois-Perret
Zip:
92300
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Benoist CHIBAUDEL, MD
Phone:
+33(0)1 47 59 59 65
Email:
benoist.chibaudel@cognacq-jay.fr
Facility:
Name:
Chu Dupuytren
Address:
City:
Limoges
Zip:
87042
Country:
France
Status:
Recruiting
Contact:
Last name:
Frédéric THUILLIER, MD
Phone:
+33(0)5 55 08 72 92
Email:
frederic.thuillier@chu-limoges.fr
Facility:
Name:
Centre Leon Berard
Address:
City:
Lyon
Zip:
69008
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Clélia COUTZAC, MD
Phone:
+33(0)4 78 78 28 28
Email:
clelia.coutzac@lyon.unicancer.fr
Facility:
Name:
Intitut Paoli Calmettes
Address:
City:
Marseille
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Christelle DE LA FOUCHARDIERE, MD
Email:
delafouchardierec@ipc.unicancer.fr
Facility:
Name:
Grand Hopital de L'Est Francilien - Site de Meaux
Address:
City:
Meaux
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Christophe LOCHER, MD
Email:
clocher@ghef.fr
Facility:
Name:
Centre Antoine Lacassagne
Address:
City:
Nice
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Ludovic EVESQUE, MD
Email:
ludovic.evesque@nice.unicancer.fr
Facility:
Name:
Aphp - Hopital Saint Louis
Address:
City:
Paris
Zip:
75010
Country:
France
Status:
Recruiting
Contact:
Last name:
Thomas APARICIO, MD
Phone:
+33(0)1 42 49 95 97
Email:
thomas.aparicio@aphp.fr
Facility:
Name:
Hopital Saint Antoine
Address:
City:
Paris
Zip:
75012
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Aphp - Hopital Bichat
Address:
City:
Paris
Zip:
75013
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Aphp - La Pitie Salpetriere
Address:
City:
Paris
Zip:
75013
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Institut Mutualiste Montsouris
Address:
City:
Paris
Zip:
75014
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Emilie SOULARUE, MD
Phone:
+33(0)1 56 61 67 20
Email:
emilie.soularue@imm.fr
Facility:
Name:
Gh Diaconesses Croix Saint Simon
Address:
City:
Paris
Zip:
75020
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Ch Perpignan
Address:
City:
Perpignan
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Chu Poitiers
Address:
City:
Poitiers
Zip:
86021
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
David TOUGERON, MD
Phone:
+33(0)5 49 44 37 51
Email:
david.tougeron@chu-poitiers.fr
Facility:
Name:
Chu de Reims
Address:
City:
Reims
Zip:
51100
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Olivier BOUCHE, MD
Phone:
+33(0)3 28 78 31 13
Email:
obouche@chu-reims.fr
Facility:
Name:
Chu Rennes Pontchaillou
Address:
City:
Rennes
Zip:
35000
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Géraldine PERKINS, MD
Email:
geraldine.perkins@chu-rennes.fr
Facility:
Name:
Chu de Rouen
Address:
City:
Rouen
Zip:
76031
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
David SEFRIOUI, MD
Phone:
+33(0)2 32 88 86 10
Email:
david.sefrioui@chu-rouen.fr
Facility:
Name:
Ch de Saint Malo
Address:
City:
Saint-Malo
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Anaïs BODERE, MD
Email:
anais.bodere@ch-dinan.fr
Facility:
Name:
ICANS
Address:
City:
Strasbourg
Zip:
67033
Country:
France
Status:
Recruiting
Contact:
Last name:
Meher BEN ABDELGHANI, MD
Phone:
+33(0)3 68 76 73 62
Email:
m.ben-abdelghani@icans.eu
Facility:
Name:
Chu de Tours
Address:
City:
Tours
Zip:
37044
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Romain CHAUTARD, MD
Phone:
+33(0)2 47 47 75 78
Email:
r.chautard@chu-tours.fr
Facility:
Name:
Chru de Nancy
Address:
City:
Vandœuvre-lès-Nancy
Zip:
54500
Country:
France
Status:
Active, not recruiting
Start date:
July 24, 2023
Completion date:
July 2028
Lead sponsor:
Agency:
UNICANCER
Agency class:
Other
Collaborator:
Agency:
Pierre Fabre Medicament
Agency class:
Industry
Source:
UNICANCER
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05639413
