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Gut Microbiota and Color-rectal Cancer. (CCR-microbiota)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04662853
Recruitment Status : Active, not recruiting
First Posted : December 10, 2020
Last Update Posted : December 10, 2020
Sponsor:
Collaborators:
Reina Sofia University Hospital
Consejería de Salud (Junta de Andalucía)
Information provided by (Responsible Party):
Maimónides Biomedical Research Institute of Córdoba

Study Description
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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.

Condition or disease Intervention/treatment
Cancer Colo-rectal Cancer Diagnoses Disease Microbiota-related Disease Intestinal Disease Diagnostic Test: Gut microbiota determination from feces samples.

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 Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 153 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 1 Month
Official Title: Gut Microbiota-based Tool for the Detection of Color-rectal Cancer in Positive Patients for the Fecal Occult Blood Test.
Actual Study Start Date : January 17, 2017
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.
 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.
Other Name: Colonoscopy


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Colonoscopy clinical results. [ Time Frame: At week 2. ]
    Prevalence of the different color-rectal cancer lessions.

  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.

  3. 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.


Biospecimen Retention:   Samples With DNA
Feces samples collected before colonoscopy.

Eligibility Criteria
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Ages Eligible for Study:   50 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04662853


Locations
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Spain
Reina Sofia University Hospital
Córdoba, Cordoba, Spain, 14004
Sponsors and Collaborators
Maimónides Biomedical Research Institute of Córdoba
Reina Sofia University Hospital
Consejería de Salud (Junta de Andalucía)
Investigators
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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
More Information
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Responsible Party: Maimónides Biomedical Research Institute of Córdoba
ClinicalTrials.gov Identifier: NCT04662853    
Other Study ID Numbers: CCR early diagnosis
First Posted: December 10, 2020    Key Record Dates
Last Update Posted: December 10, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Microbiota row data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maimónides Biomedical Research Institute of Córdoba:
Diagnosis improvement
Early diagnosis
Mathematical modelling
Gut microbiota
Colonoscopy
Additional relevant MeSH terms:
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Rectal Neoplasms
Intestinal Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
 Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Rectal Diseases