Gut Microbiota and Color-rectal Cancer. (CCR-microbiota)
December 9, 2020 updated by: Maimónides Biomedical Research Institute of Córdoba
Gut Microbiota-based Tool for the Detection of Color-rectal Cancer in Positive Patients for the Fecal Occult Blood Test.
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
153
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Cordoba
-
Córdoba, Cordoba, Spain, 14004
- Reina Sofia University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 69 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gut-microbiota-based color-rectal cancer diagnosis.
Time Frame: 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.
|
A week before colonoscopy.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Colonoscopy clinical results.
Time Frame: At week 2.
|
Prevalence of the different color-rectal cancer lessions.
|
At week 2.
|
|
Characteristic of the population.
Time Frame: 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.
|
A week before colonoscopy.
|
|
Dietary habits
Time Frame: 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.
|
A week before colonoscopy.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Antonio Hervas, Reina Sofia University Hospital
- Study Director: Carmen Haro, PhD, Maimonides Institute for Biomedical Research
- Principal Investigator: Antonio Camargo, PhD, Maimonides Institute for Biomedical Research
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 17, 2017
Primary Completion (Anticipated)
July 31, 2021
Study Completion (Anticipated)
July 31, 2021
Study Registration Dates
First Submitted
November 19, 2020
First Submitted That Met QC Criteria
December 9, 2020
First Posted (Actual)
December 10, 2020
Study Record Updates
Last Update Posted (Actual)
December 10, 2020
Last Update Submitted That Met QC Criteria
December 9, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCR early diagnosis
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
Microbiota row data.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.