Gut Microbiota and Color-rectal Cancer.

NCT04662853 | Unknown

• 1 other identifier: CCR early diagnosis
• Study Type: observational
• Target: 153
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Diagnosis improvement; Early diagnosis; Mathematical modelling; Gut microbiota; Colonoscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Colonoscopy clinical results.

  At week 2.

• Characteristic of the population.

  A week before colonoscopy.

• Dietary habits

  A week before colonoscopy.

Study Arms (1)

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.

Interventions

Gut microbiota determination from feces samples. 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.

Also known as: Colonoscopy

Patients with positive results in the fecal occult blood test.

Eligibility Criteria

• Age: 50 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

Sponsors & Collaborators

• Maimónides Biomedical Research Institute of Córdoba: lead
• Reina Sofia University Hospital: collaborator
• Junta de Andalucia: collaborator

Study Sites (1)

Reina Sofia University Hospital

Córdoba, Cordoba, 14004, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

Feces samples collected before colonoscopy.

MeSH Terms

Conditions

Neoplasms; Colonic Neoplasms; Intestinal Diseases; Disease

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Antonio Hervas

  Reina Sofia University Hospital

  STUDY DIRECTOR

• Carmen Haro, PhD

  Maimonides Institute for Biomedical Research

  STUDY DIRECTOR

• Antonio Camargo, PhD

  Maimonides Institute for Biomedical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: December 10, 2020
• Study Start: January 17, 2017
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: December 10, 2020

Record last verified: 2020-12

Locations

ES (1)