Prospective National Cohort Evaluating Predictive Biomarkers of Resistance to Immunotherapy in Patients With MSI/dMMR Metastatic Colorectal Cancer (CORESIM)
NCT ID: NCT06353854
Last Updated: 2025-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
600 participants
OBSERVATIONAL
2024-02-12
2030-02-12
Brief Summary
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Detailed Description
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CORESIM is a retrospective and prospective multicenter national French cohort. National recruitment will be carried out in all French centers, including the FFCD, AGEO, GERCOR, and UNICANCER, representing more than 150 centers and most French sites, public and private hospitals.
In France, pembrolizumab for first-line treatment of patients with MSI mCRC was accessible via its compassionate use in February 2021, then its reimbursement was effective in June 2023 Patients treated with pembrolizumab will be included prospectively on the start date of the study, i.e. on February 2024; patients treated since February 2021 via compassionate use of pembrolizumab will be included retrospectively A total of 600 patients are expected. The theoretical duration of inclusion is set at 2 years. All patients will be followed up for 3 years.
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Retrospective group
Registration of patients treated with pembrolizumab since February 2021. Collection of tumour sample archives will be associated
No interventions assigned to this group
Prospective group
Recruitment of metastatic colorectal cancer patients with microsatellite instability prior to the first administration of pembrolizumab immunotherapy. Blood and tumour sampling will be combined.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed colorectal adenocarcinoma with unresectable metastasis(s) receiving immunotherapy as first-line treatment with pembrolizumab
* Tumor with microsatellite instability determined by immunohistochemistry (loss of expression of MLH1, MSH2, MSH6 and/or PMS2) and/or by molecular biology (MSI-H on microsatellite analysis from tumor DNA according to practice routine of the center)
Exclusion Criteria
* Previous treatment with anti-PD1 or anti-PDL1.
* Previous treatment with chemotherapy +/- targeted therapy for MSI/dMMR metastatic colorectal cancer.
* Contraindication due to psychological or social reasons that may hinder follow-up (cognitive deficit, psychological disorders incompatible with obtaining non-opposition or consent; inability to be followed in the same center throughout the follow-up period for geographical reasons).
* Pregnant women
* persons under court protection or under protective supervision (guardianship or curatorship)
* Opposition to participation in the study.
18 Years
ALL
No
Sponsors
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Federation Francophone de Cancerologie Digestive
OTHER
Responsible Party
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Principal Investigators
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Aziz ZAANAN, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hôpital Européen Georges Pompidou APHP
Locations
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Ch - Centre Hospitalier de La Côte Basque
Bayonne, , France
Ch - Ch Beauvais
Beauvais, , France
CH Jean Minjoz
Besançon, , France
Polyclinique Saint Privat
Boujan-sur-Libron, , France
Ch - Duchenne
Boulogne-sur-Mer, , France
Ch - Centre Hospitalier Metropole Savoie
Chambéry, , France
Ch - Centre Hospitalier de Cholet
Cholet, , France
CH - Compiegne
Compiègne, , France
Ch - Chd Vendée
La Roche-sur-Yon, , France
CH - Louis Pasteur
Le Coudray, , France
Centre Hospitalier Regional et Universitaire de Lille
Lille, , France
CH Saint Joseph - Saint Luc
Lyon, , France
Caluire et Cuire - Infirmerie Protestante de Lyon
Lyon, , France
Ch - Hôpital Saint Joseph
Marseille, , France
CH Saint Joseph
Marseille, , France
Centre Hospitalier
Mulhouse, , France
CHR D'Orleans - Hopital de la Source
Orléans, , France
Prive - Institut Montsouris
Paris, , France
Ch - Centre Hospitalier de Soisson
Soissons, , France
CH - Gustave Dron
Tourcoing, , France
Countries
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Central Contacts
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Facility Contacts
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ANTONY TURPIN, MD
Role: primary
D. B. Vedrenne, MD
Role: primary
Jean-Paul Lagasse
Role: primary
Other Identifiers
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FFCD 2112-CORESIM
Identifier Type: -
Identifier Source: org_study_id
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