National Cohort of Colorectal Cancers With Microsatellite Instability

NCT05511688 | Active Not Recruiting DMC

• 1 other identifier: Colomin2 Cohort
• Study Type: observational
• Target: 637
• Locations: 1 country
• Sites: 14

Brief Summary

The three main pathways of colorectal carcinogenesis are chromosomal instability, microsatellite instability (MSI) (15% of colorectal cancers =CRCs) and CpG island methylator phenotype (CIMP). MSI CRCs are associated with a better prognosis after curative surgery than CRCs without microsatellite instability (MSS). In contrast, MSI CRCs do not appear to benefit from adjuvant 5-FU chemotherapy, unlike patients with MSS CRCs. Nevertheless, the benefit of adjuvant chemotherapy with FOLFOX seems to be retained. The identification of prognostic markers in this subgroup of patients is therefore essential to decide on adjuvant chemotherapy, the efficacy of which is currently debated in MSI CRC. To date, there are very few data concerning metastatic MSI CRC. Metastatic forms are rare (about 5% of metastatic CRCs), but are thought to be associated with chemoresistance and poor prognosis. Nevertheless, data are very sparse and there are no data regarding the use of modern chemotherapies and targeted therapies in metastatic MSI CRC. Thus, it is important to characterize the chemosensitivity of metastatic forms. Clinical predictors of recurrence after curative CRC surgery are known but have only been studied in MSI CRC retrospectively. Similarly, many molecular and immunohistochemical factors, prognostic or predictive of response to adjuvant chemotherapy, have been recently identified in CRC (KRAS, BRAF, TP53, PI3KCA mutations, CIMP phenotype, SMAD4, immune response...). Most of these markers have been studied in all CRCs, but not specifically in the MSI CRC subgroup. All these prognostic and/or predictive biomarkers need to be better characterized in a large cohort of MSI CRCs.

Conditions

Colorectal Cancer; Microsatellite Instability

Outcome Measures

Primary Outcomes (2)

• Progression Free Survival for stage IV colorectal cancers

  Identification of clinical, immunohistochemical and molecular prognostic factors

  from date of diagnosis up to 36 months

• Time to recurrence for stage I , II or III colorectal cancers

  Identification of clinical, immunohistochemical and molecular prognostic factors

  from date of diagnosis up to 36 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with MSI colrectal cancers (stage I to IV)

You may qualify if:

• Patient with MSI colorectal cancer defined either by molecular biology (more than 30% of microsatellites tested unstable) or by immunohistochemistry (loss of expression of at least one MMR protein: MLH1, MSH2, MSH6, PMS2)
• Histologically proven colorectal cancer diagnosed on or after January 1 of the cohort start date
• Stage I, II, III (non-metastatic) or IV (metastatic)

You may not qualify if:

• Colorectal cancer MSS
• Contraindication due to psychological, social, or geographical reasons that may hinder patient follow-up
• Opposition of the patient to registration in the cohort
• Stage 0 (Tumor in situ, N0, M0)

Sponsors & Collaborators

• Federation Francophone de Cancerologie Digestive: lead

Study Sites (14)

Chu Poitiers

Poitiers, VIENNE, 86021, France

Location

CH

Abbeville, France

Location

Chu - Hôpital Sud

Amiens, France

Location

Chu - Hôpital Hôtel Dieu

Angers, France

Location

CH

Angoulême, France

Location

Ch - Hôpital Victor Dupouy

Argenteuil, France

Location

Ch - Ght Unyon Auxerre

Auxerre, France

Location

Ch - Hôpital Henri Duffaut

Avignon, France

Location

Privé - Institut Du Cancer Avignon Provence

Avignon, France

Location

Chu - Hôpital Jean Minjoz

Besançon, France

Location

Privé- Centre Pierre Curie

Beuvry, France

Location

Ch - Centre Hospitalier de Bézier

Béziers, France

Location

Privé - Clinique Tivoli

Bordeaux, France

Location

Privé - Polyclinique Bordeaux Nord

Bordeaux, France

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Microsatellite Instability

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Genomic Instability; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• David Tougeron, MD PHD

  CHU POTIERS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2022
• First Posted: August 23, 2022
• Study Start: March 22, 2017
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 2, 2025

Record last verified: 2025-08

Locations

FR (14)