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Metastatic Colorectal CancerCOBRAFNCT05639413

A Clinical-biological Prospective Cohort of Patients With BRAFV600E-mutated Metastatic Colorectal Cancer

A study testing Collection of blood samples in people with Metastatic Colorectal Cancer and BRAF V600E Mutation Positive, run by UNICANCER at 45 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Collection of blood samples
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
45 sitesFrance
Study dates
24 Jul 2023to Jul 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

45 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Emilie BRUMENT contact

+33(0)1 71 93 61 64

e-brument@unicancer.fr

Anne-Sophie BACH, PHD contact

+33(0)6 10 33 00 51

as-bach@unicancer.fr

45 sites in 1 country

France45 sites, 31 recruiting

  • Centre Hospitalier D'Avignon

    Avignon, 84000

    Active, not recruiting

  • Centre Hospitalier de Bayeux

    Bayeux, 14400

    Annie PEYTIER, MD, a.peytier@ch-ab.fr

    Recruiting

  • Chu Simone Veil

    Beauvais

    Active, not recruiting

  • Institut Bergonie

    Bordeaux, 33076

    Lola-Jade PALMIERI, MD, +33(0)5 56 33 33 33, l.palmieri@bordeaux.unicancer.fr

    Recruiting

  • CH Fleyriat

    Bourg-en-Bresse, 01000

    Active, not recruiting

  • Ch de Cahors

    Cahors

    Slim LASSOUED, MD, slim.lassoued@ch-cahors.fr

    Recruiting

  • CH Dr TECHER

    Calais, 62107

    Active, not recruiting

  • Infirmerie Protestante de Lyon

    Caluire-et-Cuire

    Active, not recruiting

  • Chu Estaing de Clermont-Ferrand

    Clermont-Ferrand, 63003

    Marine JARY, MD, +33(0)4 73 75 05 08, mjary@chu-clermontferrand.fr

    Recruiting

  • GHPSO

    Creil

    Elisabeth CAROLA, MD

    Recruiting

  • Aphp - Hopital Henri Mondor

    Créteil

    Charlotte FENIOUX, MD, charlotte.fenioux@aphp.fr

    Recruiting

  • Groupe Hospitalier Mutualiste de Grenoble

    Grenoble, 38028

    Withdrawn

  • Chu de Grenoble Alpes - Hopital Michallon

    La Tronche, 38700

    Withdrawn

  • CH Louis Pasteur

    Le Coudray, 28630

    David SOLUB, MD

    Not yet recruiting

  • Groupe Hospitalier Emile Roux

    Le Puy-en-Velay

    Vanessa PANTE, MD, vanessa.pante@ch-lepuy.fr

    Recruiting

  • Hopital Franco-Britannique

    Levallois-Perret, 92300

    Active, not recruiting

  • Chu Dupuytren

    Limoges, 87042

    Frédéric THUILLIER, MD, +33(0)5 55 08 72 92, frederic.thuillier@chu-limoges.fr

    Recruiting

  • Centre Leon Berard

    Lyon, 69008

    Clélia COUTZAC, MD, +33(0)4 78 78 28 28, clelia.coutzac@lyon.unicancer.fr

    Recruiting

  • Hôpital privé Jean Mermoz

    Lyon, 69373

    Active, not recruiting

  • Hopital de La Timone

    Marseille

    Laëtitia DAHAN, MD

    Not yet recruiting

  • Intitut Paoli Calmettes

    Marseille

    Christelle DE LA FOUCHARDIERE, MD, delafouchardierec@ipc.unicancer.fr

    Recruiting

  • Grand Hopital de L'Est Francilien - Site de Meaux

    Meaux

    Active, not recruiting

  • Centre Antoine Lacassagne

    Nice

    Ludovic EVESQUE, MD, ludovic.evesque@nice.unicancer.fr

    Recruiting

  • CHR d'Orléans

    Orléans, 45100

    Active, not recruiting

  • Aphp - Hopital Saint Louis

    Paris, 75010

    Thomas APARICIO, MD, +33(0)1 42 49 95 97, thomas.aparicio@aphp.fr

    Recruiting

  • Hopital Saint Antoine

    Paris, 75012

    Romain COHEN, MD, +33(0)1 49 28 23 36, romain.cohen@aphp.fr

    Recruiting

  • Aphp - Hopital Bichat

    Paris, 75013

    Gaël GOUJON, MD, +33(0)1 40 25 87 16, gael.goujon@aphp.fr

    Recruiting

  • Aphp - La Pitie Salpetriere

    Paris, 75013

    Jean-Baptiste BACHET, MD, +33(0)1 42 16 10 41, jean-baptiste.bachet@aphp.fr

    Recruiting

  • Institut Mutualiste Montsouris

    Paris, 75014

    Emilie SOULARUE, MD, +33(0)1 56 61 67 20, emilie.soularue@imm.fr

    Recruiting

  • Gh Diaconesses Croix Saint Simon

    Paris, 75020

    Olivier DUBREUIL, MD, +33(0)1 44 74 23 39, odubreuil@hopital-dcss.org

    Recruiting

  • Hopital Europeen Georges Pompidou

    Paris

    Claire GALLOIS, MD

    Recruiting

  • Ch Perpignan

    Perpignan

    Faiza KHEMISSA, MD, 04 68 61 89 01, faiza.khemissa@ch-perpignan.fr

    Recruiting

  • Chu Poitiers

    Poitiers, 86021

    David TOUGERON, MD, +33(0)5 49 44 37 51, david.tougeron@chu-poitiers.fr

    Recruiting

  • Chu de Reims

    Reims, 51100

    Olivier BOUCHE, MD, +33(0)3 28 78 31 13, obouche@chu-reims.fr

    Recruiting

  • Chu Rennes Pontchaillou

    Rennes, 35000

    Géraldine PERKINS, MD, geraldine.perkins@chu-rennes.fr

    Recruiting

  • Chu de Rouen

    Rouen, 76031

    David SEFRIOUI, MD, +33(0)2 32 88 86 10, david.sefrioui@chu-rouen.fr

    Recruiting

  • Hôpital Privé de la Loire

    Saint-Etienne, 42100

    Active, not recruiting

  • Hnia Begin

    Saint-Mandé

    Active, not recruiting

  • Ch de Saint Malo

    St-Malo

    Active, not recruiting

  • Centre Paul Strauss

    Strasbourg, 67033

    Meher BEN ABDELGHANI, MD, +33(0)3 68 76 73 62, m.ben-abdelghani@icans.eu

    Recruiting

  • Hnia Saint Anne

    Toulon

    Caroline PRIEUX-KLOTZ, MD

    Not yet recruiting

  • Chu de Tours

    Tours, 37044

    Romain CHAUTARD, MD, +33(0)2 47 47 75 78, r.chautard@chu-tours.fr

    Recruiting

  • Chru de Nancy

    Vandœuvre-lès-Nancy, 54500

    Marie MULLER, MD, 03 83 15 51 79, M.MULLER7@chru-nancy.fr

    Recruiting

  • Institut de Cancerologie de Lorraine

    Vandœuvre-lès-Nancy

    Edwige BAUDRY, MD

    Not yet recruiting

  • Centre d'Oncologie Saint Yves

    Vannes, 56000

    Valentine DISDERO, MD

    Recruiting

Other trials in France

About this study

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

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.

Read the 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:

  1. 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.
Being tested
Collection of blood samples
Keywords
Clinical-biological cohort, Colorectal Cancer, BRAF mutation
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Collection of blood samplesOther

    A 30 mL blood samples (6 mL in each of 5 EDTA tubes) will be collected from each patient at each timepoint.

Study groups in NCT05639413
Study groupRoleWhat they receive
COBRAFOtherA 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.
Receives: Other: Collection of blood samples

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From date of first diagnosis of mCRC and the date of death, whatever the cause, up to 5 years

Secondary outcomes (8)

  1. Collection of prospective data about BRAFV600E mCRC

    Prospective collection of data collected during the normal clinical care. A descriptive analysis of the disease (Patients and tumors characteristics), current medical practices (molecular genotyping in France), and therapeutic sequences and composition of each treatment line (patients treated with immunotherapy, patients enrolled in clinical studies, metastatic surgeries). The resulting qualitative data analysis of the population will be expressed in number with percentage.

    Measured: Throughout study completion, up to 5 years

  2. Correlation between prognostic markers and progression-free survival

    PFS is defined as the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse. PFS will then be correlated to clinical and biological prognostic markers analyzed at date of first diagnosis of mCRC and date of first progression or death by clinical testing used in routine cancer treatment practice (blood test analysis and tumor sample analysis). The Cox proportional-hazards model will then be used to study potential prognostic parameters PFS.

    Measured: From date of first diagnosis of mCRC and date of first progression or death, up to 5 years

  3. Correlation between prognostic markers and overall survival

    To identify clinical and biological prognostic markers of OS on blood and tumor samples. the OS is defined as the length of time from first diagnosis of mCRC that patients enrolled in the study are still alive. OS will then be correlated to clinical and biological prognostic markers analyzed at date of first diagnosis of mCRC and date of first progression or death by clinical testing used in routine cancer treatment practice (blood test analysis and tumor sample analysis). The Cox proportional-hazards model will then be used to study potential prognostic parameters OS.

    Measured: Throughout study completion, up to 5 years

  4. Objective response rate

    The objective response rate (ORR) for each treatment line is defined as the percentage of patients with a complete response (CR) or a partial response (PR) for a given treatment line.

    Measured: From baseline to first disease progression, up to 5 years

  5. Disease control rate

    The disease control rate (DCR) is defined as the percentage of patients with a CR, a PR or stable disease for a given treatment line.

    Measured: From baseline to first disease progression, up to 5 years

  6. Progression-free survival

    The progression-free survival (PFS) for each treatment line is defined as the time interval between the start of treatment of the given line and the date of the first disease progression (radiological or clinical) or the start of another anticancer therapy, or death from any cause, whichever occurs first.

    Measured: From baseline to first disease progression, up to 5 years

  7. ctDNA kinetics modeling outcome parameters

    The detection of ctDNA level assessed by next generation sequencing in the blood of patients with deficient DNA mismatch repair (dMMR) / microsatellite instability (MSI) will be measured at the start of cycle 1, cycle 2, and cycle 3, and at 3 months and 6 months after starting each treatment line, as well as at disease progression.

    The level of ctDNA measured at each time point will provide information on how the body interacts with administered treatments overtime.

    Measured: From date of first diagnosis of mCRC until the date of first disease progression, up to 5 years

  8. Correlation between predictive biomarkers and response to treatment

    These biomarkers of response/resistance to combination treatment with anti-EGFR/anti-BRAF will be assessed by immunohistochemistry analysis of peripheral blood and tumor tissues.

    Measured: Throughout study completion, up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2022
  2. Study start24 Jul 2023
  3. Primary completionJul 2027 (estimated)
  4. Study completionJul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
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.
Masking
None (open label)
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05639413
Sponsor's protocol ID
UC-GIG-2210/PRODIGE75
Other IDs
2022-A02232-41
Acronym
COBRAF
Status last verified
Dec 2025
First submitted
15 Nov 2022
Last updated
10 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A study testing Collection of blood samples in people with Metastatic Colorectal Cancer and BRAF V600E Mutation Positive, run by UNICANCER at 45 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Emilie BRUMENT (+33(0)1 71 93 61 64, e-brument@unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: From date of first diagnosis of mCRC and the date of death, whatever the cause, up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05639413.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.

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