NCT04662853

Gut Microbiota and Color-rectal Cancer.

Gut Microbiota-based Tool for the Detection of Color-rectal Cancer in Positive Patients for the Fecal Occult Blood Test.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 153 (actual)
• Sponsor: Maimónides Biomedical Research Institute of Córdoba · Academic / Other
• Sex: All
• Age: 50 Years – 69 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer
• Colo-rectal Cancer
• Diagnoses Disease
• Microbiota-related Disease
• Intestinal Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Gut microbiota determination from feces samples.	Determination of the gut microbiota composition by 16S metagenomic and building of a mathematical model, on the basis of the colonoscopies results, able to classify patients without and with color-rectal cancer-related lessions. These latter will be also classified according to the type of lession.

Timeline

• Start date: 2017-01-17
• Primary completion: 2021-07-31
• Completion: 2021-07-31
• First posted: 2020-12-10
• Last updated: 2020-12-10

Locations

1 site across 1 country: Spain