An observational study in Cancer, Colo-rectal Cancer and Diagnoses Disease, sponsored by Maimónides Biomedical Research Institute of Córdoba. Status unknown at 1 site in Spain. Open to participants aged 50 Years to 69 Years. Per ClinicalTrials.gov, last updated 2020-12-10.
Sponsored by Maimónides Biomedical Research Institute of Córdoba · Observational
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.
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.
1,762 studies on the registry are indexed under Rectal Neoplasms; 517 are open to participants now.
This study's enrollment of 153 is close to the median of 160 across 413 observational studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →Maimónides Biomedical Research Institute of Córdoba is the lead sponsor of 78 studies on the registry; 20 are open to participants now.
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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.
-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.
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.
Also known as: Colonoscopy
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.
Time frame: A week before colonoscopy.
Colonoscopy clinical results.
Prevalence of the different color-rectal cancer lessions.
Time frame: 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.
Time frame: 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.
Time frame: A week before colonoscopy.
Plan to share: Undecided — Microbiota row data.
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This study is status unknown, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Maimónides Biomedical Research Institute of Córdoba