Clinical trial NCT04662853: Gut Microbiota and Color-rectal Cancer.
Official title: Gut Microbiota-based Tool for the Detection of Color-rectal Cancer in Positive Patients for the Fecal Occult Blood Test.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Colo-rectal Cancer
Diagnoses Disease
Microbiota-related Disease
Intestinal Disease
Keywords: Diagnosis improvement
Early diagnosis
Mathematical modelling
Gut microbiota
Colonoscopy
Lead sponsor: Maimónides Biomedical Research Institute of Córdoba
Sponsor class: OTHER
Collaborators: name: Reina Sofia University Hospital
name: Junta de Andalucia
First posted: 2020-12-10
Enrollment: 153
Sex: ALL
Minimum age (years): 50
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Gut-microbiota-based color-rectal cancer diagnosis.
timeFrame: A week before colonoscopy.
Secondary outcomes:
measure: Colonoscopy clinical results.
timeFrame: At week 2.
measure: Characteristic of the population.
timeFrame: A week before colonoscopy.
measure: Dietary habits
timeFrame: A week before colonoscopy.
Other outcomes:
Locations:
city: Córdoba
country: Spain
facility: Reina Sofia University Hospital
state: Cordoba
Study officials:
affiliation: Reina Sofia University Hospital
name: Antonio Hervas
role: STUDY_DIRECTOR
affiliation: Maimonides Institute for Biomedical Research
name: Carmen Haro, PhD
role: STUDY_DIRECTOR
affiliation: Maimonides Institute for Biomedical Research
name: Antonio Camargo, PhD
role: PRINCIPAL_INVESTIGATOR
References: