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NCT05511688Completed

National Cohort of Colorectal Cancers With Microsatellite Instability

Source: ClinicalTrials.gov · Last updated 30 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
637 (actual)
First submitted
24 Mar 2022
Start date
22 Mar 2017
Primary completion date
7 Aug 2025
Lead sponsor
Federation Francophone de Cancerologie Digestive
NCT number
NCT05511688

What you commit to

  • Study type: Observational
  • Participants enrolled: 637
  • From 22 Mar 2017 to the primary completion date, 7 Aug 2025
  • 14 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Colorectal cancer MSS

Other

  • 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)

Who the study is looking for

  • 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)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (14)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CH
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AbbevilleFranceUnknown status
Chu - Hôpital Sud
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AmiensFranceUnknown status
Chu - Hôpital Hôtel Dieu
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AngersFranceUnknown status
CH
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AngoulêmeFranceUnknown status
Ch - Hôpital Victor Dupouy
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ArgenteuilFranceUnknown status
Ch - Ght Unyon Auxerre
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AuxerreFranceUnknown status
Privé - Institut Du Cancer Avignon Provence
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AvignonFranceUnknown status
Ch - Hôpital Henri Duffaut
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AvignonFranceUnknown status
Chu - Hôpital Jean Minjoz
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BesançonFranceUnknown status
Privé- Centre Pierre Curie
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BeuvryFranceUnknown status
Ch - Centre Hospitalier de Bézier
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BéziersFranceUnknown status
Privé - Clinique Tivoli
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BordeauxFranceUnknown status
Privé - Polyclinique Bordeaux Nord
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BordeauxFranceUnknown status
CHU Poitiers
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PoitiersFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.