Gut Microbiota and Color-rectal Cancer.

Cancer Clinical Trial

— CCR-microbiota  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04662853
• Other study ID #: CCR early diagnosis
• Status: Active, not recruiting
• Start date: January 17, 2017
• Est. completion date: July 31, 2021

Study information

• Verified date: December 2020
• Source: Maimónides Biomedical Research Institute of Córdoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 153
• Est. completion date: July 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 69 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Colo-rectal Cancer
• Diagnoses Disease
• Intestinal Disease
• Intestinal Diseases
• Microbiota-related Disease
• Rectal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Spain	Reina Sofia University Hospital	Córdoba	Cordoba

Sponsors (3)

Lead Sponsor	Collaborator
Maimónides Biomedical Research Institute of Córdoba	Consejería de Salud (Junta de Andalucía), Reina Sofia University Hospital

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Colonoscopy clinical results.	Prevalence of the different color-rectal cancer lessions.	At week 2.
Secondary	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.
Secondary	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.