Clinical trial NCT06368661: Dietary Factors Associated to Colorectal Premalignant Lesions (COLOMAR-1)
Official title: Dietary Factors Associated to Colorectal Premalignant Lesions (COLOMAR-1)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Nutrition Related Neoplasm/Cancer
Keywords: Fish
Colon cancer
Rectal cancer
Lead sponsor: Fundación Vithas
Sponsor class: OTHER
Collaborators: name: CEU San Pablo University
First posted: 2024-04-16
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers from the general population above 45 years old.

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.

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)

Eligibility criteria: 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.

Primary outcomes:
measure: Dietary habits registry from participants: the dietary intake
timeFrame: 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
measure: Biomarkers in colon mucosa, precancerous lesions and colorectal cancer
timeFrame: 3 months
measure: Gut microbiota profile
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vigo
country: Spain
facility: Ciro Cabezas Checchi
state: Pontevedra
Study officials:
References: