Status:
RECRUITING
The French Gut-colo
Lead Sponsor:
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Collaborating Sponsors:
Assistance Publique - Hôpitaux de Paris
Conditions:
Patients Aged 50-75 and Requiring Colonoscopy
Eligibility:
All Genders
50-75 years
Brief 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 cal...
Detailed Description
Many CRC risk factors, such as obesity, low physical activity, a diet low in fibre and high in fat and red meat, and chronic inflammation of the gastrointestinal tract, are known to interact with the ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 26 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 25 2028
Estimated Enrollment :
2500 Patients enrolled
Trial Details
Trial ID
NCT06174233
Start Date
June 26 2024
End Date
June 25 2028
Last Update
September 16 2025
Active Locations (1)
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1
Hopital Avicenne, Centre de Recherche sur Volontaire
Bobigny, France, 93000