Clinical trial · Observational
National Cohort of Colorectal Cancers With Microsatellite Instability
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Microsatellite Instability | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Progression Free Survival for stage IV colorectal cancers
- timeFrame
- from date of diagnosis up to 36 months
- description
- Identification of clinical, immunohistochemical and molecular prognostic factors
- measure
- Time to recurrence for stage I , II or III colorectal cancers
- timeFrame
- from date of diagnosis up to 36 months
- description
- Identification of clinical, immunohistochemical and molecular prognostic factors
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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) Exclusion Criteria: * 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)
References
Publications (0)
Data not yet available