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

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.

Study Overview

• Status: Recruiting
• Conditions: Nutrition Related Neoplasm/Cancer

Detailed 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.
4. To describe microbiota composition in all the participants.
5. To determinate correlation between dietary habits and clinical and molecular findings of the study.
6. To calculate the overall sample size of the entire research program (ColoMAR-2) in base to dietary patterns and Alkylating signature prevalence of the participants)

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

Study Locations

• Spain
  • Pontevedra
    • Vigo, Pontevedra, Spain, 36206
      • Recruiting
      • Ciro Cabezas Checchi
      • Contact: Ciro Cabezas Checchi, MD; Phone Number: +34 986 82 11 00; Email: CabezasCC@vithas.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers from the general population above 45 years old.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Fundación Vithas
• Collaborators: CEU San Pablo University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: April 11, 2024
• First Submitted That Met QC Criteria: April 11, 2024
• First Posted (Actual): April 16, 2024

Study Record Updates

• Last Update Posted (Actual): July 30, 2024
• Last Update Submitted That Met QC Criteria: July 28, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Rectal cancer; Colon cancer; Fish
• Additional Relevant MeSH Terms: Neoplasms; Precancerous Conditions
• Other Study ID Numbers: 23.79 Colo-MAR 1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No