Gut Microbiota and Color-rectal Cancer.

• Conditions: Colo-rectal Cancer; Intestinal Disease; Cancer; Diagnoses Disease; Microbiota-related Disease
• Interventions: Diagnostic Test: Gut microbiota determination from feces samples.

• Registration Number: NCT04662853
• Lead Sponsor: Maimónides Biomedical Research Institute of Córdoba

Brief Summary

This clinical trial is focused in the development of a screening test for the people at risk of colo-rectal cancer (aged more than 50 years old), valid and safe, improving the screening prognosis increasing the sensitivity and sensitive as compared with the current method, fecal occult blood.

Detailed Description

Colo-rectal cancer (CCR) is one of the most prevalent cancers in developed countries. Several studies suggest that the CCR may be related with changes in the gut microbiota. This clinical trial is focused in the development of a screening test for the people at risk of CCR (aged more than 50 years old), valid and safe, improving the screening prognosis. The main potential improvement lies in the fact that the proposed method is more specific and sensitive than the current method, fecal occult blood. It aims to distinguish whether the positive results for fecal occult blood test is due to fissures, not related with CCR (which are positive for fecal occult blood, false positive) or was caused by a cancer-related lesion. The methodology derived will also improve the sensitive as sometimes the polyps do not leak blood. Based in the previous differences found in the gut microbiota composition related with CCR for several research groups, the gut microbiota composition will be used as diagnosis tool.

Study Timeline

• Study Start: 2017-01-17
• Study First Submitted: 2020-11-19
• Status Verified: 2020-12
• Study First Submitted QC: 2020-12-09
• Last Update Submitted: 2020-12-09
• Study First Posted: 2020-12-10
• Last Update Posted: 2020-12-10
• Primary Completion: 2021-07-31
• Study Completion: 2021-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 153

Inclusion Criteria

-Patients with positive results in the fecal occult blood test in the Program for Early Detection of Colon and Rectal Cancer, undergone by the Consejeria de Salud de la Junta de Andalucia (Spain).

Exclusion Criteria

-The consumption of antibiotic within the previous month to inclusion in the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with positive results in the fecal occult blood test.	Gut microbiota determination from feces samples.	Patients with positive results in the fecal occult blood test in the Program for Early Detection of Colon and Rectal Cancer, undergone by the Consejeria de Salud de la Junta de Andalucia (Spain), were invited to participate in the CCR-microbiome study. This program is screening Andalusian population aged between 50 and 69 years old for colo-rectal cancer presence by fecal occult blood test, and further colonoscopy when positive for this test. Patients included in CCR-microbiome study were recruited between January 2017 and March 2020, at the Reina Sofia University Hospital (Cordoba, Spain) with the consumption of antibiotic within the previous month as exclusion criteria.

Primary Outcome Measures

Name	Time	Method
Gut-microbiota-based color-rectal cancer diagnosis.	A week before colonoscopy.	Determination of the gut microbiota composition by 16S metagenomic, data analysis and building of a mathematical model to test the potential use of the gut microbiota architecture as biomarker to color-rectal cancer prognosis in patients with positive results in fecal occult blood test.

Secondary Outcome Measures

Name	Time	Method
Colonoscopy clinical results.	At week 2.	Prevalence of the different color-rectal cancer lessions.
Dietary habits	A week before colonoscopy.	The dietary habits will be assessed by a questionnaire and will be used to check for any association with the prevalence of the different color-rectal cancer lessions.
Characteristic of the population.	A week before colonoscopy.	The characteristic of the population includes gender (man/woman), age (years), weight in kilograms and height in meters (weight and height will be combined to report BMI in kg/m\^2), which will be used to check for any association with the prevalence of the different color-rectal cancer lesions.

Trial Locations

Locations (1)

Reina Sofia University Hospital; 🇪🇸 Córdoba, Cordoba, Spain