Ireland
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Recruiting Observational

The French Gut-colo

NCT06174233 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2024-06-26
Last updated
2025-09-16

Condition(s) studied

Patients Aged 50-75 and Requiring Colonoscopy

Study summary

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.

Eligibility

Sex
ALL
Min age
50 Years
Max age
75 Years
Healthy volunteers
Accepted
Inclusion Criteria: * 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 Exclusion Criteria: * 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; * Antibiotics taken in the 3 months prior to inclusion (self-report); * Person aged under 50 or over 75.

Primary outcome measure(s)

  • Measurement of true-negative, true-positive, false-negative and false-positive rates after colonoscopy, associated with the new test based on metagenomic analysis and clinical data. — up to 4 years

Trial sites (1)

FacilityCityRegionStatus
Hopital Avicenne, Centre de Recherche sur Volontaire Bobigny France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06174233 on ClinicalTrials.gov ↗ ← All trials in France