CCR-microbiota: Gut Microbiota and Color-rectal Cancer.

Sponsor

Maimónides Biomedical Research Institute of Córdoba (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04662853

Collaborator

Reina Sofia University Hospital (Other), Consejería de Salud (Junta de Andalucía) (Other)

153

Enrollment

Location

54.4

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer Colo-rectal Cancer Diagnoses Disease Microbiota-related Disease Intestinal Disease	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 Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

153 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 17, 2017

Anticipated Primary Completion Date :

Jul 31, 2021

Anticipated Study Completion Date :

Jul 31, 2021

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

Colonoscopy clinical results. [At week 2.]
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 69 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Reina Sofia University Hospital	Córdoba	Cordoba	Spain	14004

Sponsors and Collaborators

Maimónides Biomedical Research Institute of Córdoba
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