Gut Microbiota and Color-rectal Cancer. (CCR-microbiota)

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

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.

Study Overview

• Status: Unknown
• Conditions: Cancer; Diagnoses Disease; Colo-rectal Cancer; Intestinal Disease; Microbiota-related Disease
• Intervention / Treatment: Diagnostic test: Gut microbiota determination from feces samples.

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 Type: Observational
• Enrollment (Actual): 153

Contacts and Locations

Study Locations

• Spain
  • Cordoba
    • Córdoba, Cordoba, Spain, 14004
      • Reina Sofia University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

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.; Other Names: Colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gut-microbiota-based color-rectal cancer diagnosis.	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.	A week before colonoscopy.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Colonoscopy clinical results.	Prevalence of the different color-rectal cancer lessions.	At week 2.
Characteristic of the population.	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.	A week before colonoscopy.
Dietary habits	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.	A week before colonoscopy.

Collaborators and Investigators

• Sponsor: Maimónides Biomedical Research Institute of Córdoba
• Collaborators: Reina Sofia University Hospital; Consejería de Salud (Junta de Andalucía)
• Investigators: Study Director: Antonio Hervas, Reina Sofia University Hospital; Study Director: Carmen Haro, PhD, Maimonides Institute for Biomedical Research; Principal Investigator: Antonio Camargo, PhD, Maimonides Institute for Biomedical Research

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2017
• Primary Completion (Anticipated): July 31, 2021
• Study Completion (Anticipated): July 31, 2021

Study Registration Dates

• First Submitted: November 19, 2020
• First Submitted That Met QC Criteria: December 9, 2020
• First Posted (Actual): December 10, 2020

Study Record Updates

• Last Update Posted (Actual): December 10, 2020
• Last Update Submitted That Met QC Criteria: December 9, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Colonoscopy; Gut microbiota; Early diagnosis; Mathematical modelling; Diagnosis improvement
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Disease; Rectal Neoplasms; Intestinal Diseases
• Other Study ID Numbers: CCR early diagnosis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Microbiota row data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No