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NCT06174233Recruiting

The French Gut-colo

"Contribution of Metagenomic Analysis of Faecal Microbiota Combined With Artificial Intelligence for the Prediction of Colorectal Cancer Risk; Study in Patients Scheduled for Colonoscopy".

Source: ClinicalTrials.gov · Last updated 29 Oct 2026

Brief summary (registry, in English)

Colorectal cancer (CRC) is the second most common type of cancer worldwide. The European Union recommends national CRC screening for people aged between 50 and 74. Generally, an immunological test called FIT (Fecal Immunochemical Test), based on the quantitative detection of human haemoglobin, is performed on a stool sample. If the haemoglobin level is above the recommended threshold, a colonoscopy is recommended to detect colorectal lesions. Recent studies have identified potential microbiota signatures associated with colon cancer. In this study, we will analyze the microbiota of a population aged 50 to 75 years undergoing colonoscopy as part of routine care in order to confirm the presence of microbiota signatures associated with the presence of adenomas, advanced adenomas and CRC.

Status (registry)
Recruiting
Study type
Observational
Enrollment
2500 (estimated)
First submitted
8 Dec 2023
Start date
17 Jun 2024
Primary completion date
17 Jun 2029
Lead sponsor
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
NCT number
NCT06174233

What you commit to

  • Study type: Observational
  • Planned participants: 2500
  • From 17 Jun 2024 to the primary completion date, 17 Jun 2029
  • 1 site 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.

Prior treatment

  • Antibiotics taken in the 3 months prior to inclusion (self-report);

Age

  • Person aged under 50 or over 75.

Other

  • Persons not living in France (declaratory);
  • Persons subject to a protective measure, in particular guardianship or trusteeship, or unable to express their consent (declarative);
  • Persons who have had a colectomy (declaratory);
  • Person with a digestive stoma (declaration);
  • Person who did not sign the consent form;
  • Person who did not answer the entry questionnaire;
  • Person who did not send a compliant stool sample;

Who the study is looking for

  • Between the ages of 50 and 75
  • Requiring colonoscopy
  • Able to provide a faecal sample and to perform a FIT test prior to colonoscopy
  • Without known inflammatory bowel disease (chronic inflammatory bowel disease (IBD), chronic ulcerative colitis (CUC) and Crohn's disease (CD))
  • No medical condition that, in the opinion of the investigator, should preclude inclusion in the study
  • Not having participated in any other clinical research study in which an investigational drug has been administered within 60 days prior to and including the date of informed consent or is likely to be administered during the period of colonoscopy
  • Participation agreement signed electronically

Age in the registry: 50 years to 75 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

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

SiteCityCountrySite status
Hopital Avicenne, Centre de Recherche sur Volontaire
Coordinator of this site? Confirm its status
BobignyFranceRecruiting

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