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

NCT06368661 | Recruiting

• 1 other identifier: 23.79 Colo-MAR 1
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nutrition Related Neoplasm/Cancer

Keywords

Fish; Colon cancer; Rectal cancer

Outcome Measures

Primary Outcomes (3)

• 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

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers from the general population above 45 years old.

You may qualify if:

• years old or more.
• Be willing to participate in the study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Vithas: lead
• CEU San Pablo University: collaborator

Study Sites (1)

Ciro Cabezas Checchi

Vigo, Pontevedra, 36206, Spain

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Colon mucosa and blood samples will be taken to find alkylating signature and dismiss other genetic patterns.

MeSH Terms

Conditions

Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: April 16, 2024
• Study Start: September 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: December 31, 2024
• Last Updated: July 30, 2024

Record last verified: 2024-04

Locations

ES (1)