Dietary Factors Associated to Colorectal Premalignant Lesions (COLOMAR-1)

Nutrition Related Neoplasm/Cancer Clinical Trial

Official title:

Dietary Factors Associated to Colorectal Premalignant Lesions (COLOMAR-1)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06368661
• Other study ID #: 23.79 Colo-MAR 1
• Status: Recruiting
• Start date: September 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Fundación Vithas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to find a correlation between fish protein intake and other dietary habits and colorectal premalignant lesions in healthy volunteers. It also aims to describe gut microbial profiles for each dietary pattern, in order to elucidate the role of fish intake in cancer prevention.

Description:

Colorectal cancer incidence is increasing in developed countries specially among young adults due to risk factors as modern dietary, smoking, low physical exercise and obesity. Some foods (fruits, vegetables, nuts, other seeds and legumes) are assumed to prevent occurrence of colorectal cancer, while red and processed meat intake are strongly associated with increased risk of colorectal tumors. However, evidence on fish intake is still scarce, and the mechanisms and drivers of their potential health benefits are also only partially known. On the other hand, colonoscopy remains the gold standard for colon cancer screening. Our study aims to explore the relationship among fish intake, microbiota and molecular alterations during a colonoscopy screening program of healthy volunteers. This is a preliminary proof-of-concept study (ColoMAR-1) to evaluate the feasibility of the entire research program (ColoMAR-2).

The main objectives of this pilot are:

1. To determinate the feasibility of the entire research project obtaining data for all the study participants (colonoscopy, blood sample, feces sample and dietary questionnaire).

2. To evaluate the presence of precancerous lesions (colonic polyps) and colorectal malignant tumors in all the participants.

3. To find molecular alterations (Alkylating signature) in normal mucosa of right and left-sided colon samples.

5. To describe microbiota composition in all the participants. 6. To determinate correlation between dietary habits and clinical and molecular findings of the study.

7. To calculate the overall sample size of the entire research program (ColoMAR-2) in base to dietary patterns and Alkylating signature prevalence of the participans)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• 45 years old or more.

• Be willing to participate in the study.

Exclusion Criteria:

• Pregnancy

• Previous colorectal cancer.

• Familial colorectal cancer syndrome.

• Previous colonoscopy and colon polypectomy (last five years ).

• Inflammatory bowel disease.

• Medical contraindication for colonoscopy at investigator´s criteria.

Related Conditions & MeSH terms

• Neoplasms
• Nutrition Related Neoplasm/Cancer
• Precancerous Conditions

Locations

Country	Name	City	State
Spain	Ciro Cabezas Checchi	Vigo	Pontevedra

Sponsors (2)

Lead Sponsor	Collaborator
Fundación Vithas	CEU San Pablo University

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dietary habits registry from participants: the dietary intake	Dietary habits will be taken by an online specific Food Frequency Questionnaire (FFQ) for Spanish population. The data analysis will be taken at baseline outcome.	Dietary habits will be taken by an online specific Food Frequency Questionnaire (FFQ) for Spanish population. The data analysis will be taken at baseline outcome. 3 months
Primary	Biomarkers in colon mucosa, precancerous lesions and colorectal cancer	Alkylating signature will be determined in normal mucosa of right and left colon, premalignant lesions and colorectal cancer	3 months
Primary	Gut microbiota profile	Differences in profile of gut microbiota among participants with and without precancerous lesions and colorectal cancer will be evaluated. Differences in profile of gut microbiota among different profiles of dietary habits will be evaluated.	4 months