Cancer, Colo-rectal Cancer, Diagnoses Disease, Intestinal Disease, Microbiota-related Disease
Conditions
Keywords
Diagnosis improvement, Early diagnosis, Mathematical modelling, Gut microbiota, Colonoscopy
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.
Interventions
DIAGNOSTIC_TESTGut 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.
Sponsors
Reina Sofia University Hospital
Junta de Andalucia
Maimónides Biomedical Research Institute of Córdoba
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to 69 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Spain
Outcome results
None listed