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National Cohort of Colorectal Cancers With Microsatellite Instability

NCT05511688 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 637

Last updated 2025-09-02

No results posted yet for this study

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

Sponsors & Collaborators

  • Federation Francophone de Cancerologie Digestive

    lead OTHER

Principal Investigators

  • David Tougeron, MD PHD · CHU POTIERS

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-22
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05511688 on ClinicalTrials.gov