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Gut Microbiota and Color-rectal Cancer.

NCT ID: NCT04662853

Last Updated: 2020-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

153 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-17

Study Completion Date

2021-07-31

Brief Summary

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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

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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

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

Keywords

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Diagnosis improvement Early diagnosis Mathematical modelling Gut microbiota Colonoscopy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with positive results in the fecal occult blood test.

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.

Gut microbiota determination from feces samples.

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Colonoscopy

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Reina Sofia University Hospital

UNKNOWN

Sponsor Role collaborator

Junta de Andalucia

OTHER_GOV

Sponsor Role collaborator

Maimónides Biomedical Research Institute of Córdoba

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Antonio Hervas

Role: STUDY_DIRECTOR

Reina Sofia University Hospital

Carmen Haro, PhD

Role: STUDY_DIRECTOR

Maimonides Institute for Biomedical Research

Antonio Camargo, PhD

Role: PRINCIPAL_INVESTIGATOR

Maimonides Institute for Biomedical Research

Locations

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Reina Sofia University Hospital

Córdoba, Cordoba, Spain

Site Status

Countries

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Spain

Other Identifiers

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CCR early diagnosis

Identifier Type: -

Identifier Source: org_study_id