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临床试验/NCT06368661
NCT06368661招募中不适用

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

Fundación Vithas1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
Biomarkers in colon mucosa, precancerous lesions and colorectal cancer

研究概览

简要总结

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.

详细描述

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)

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Cross Sectional

入排标准

年龄范围
45 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

Biomarkers in colon mucosa, precancerous lesions and colorectal cancer

时间窗: 3 months

Alkylating signature will be determined in normal mucosa of right and left colon, premalignant lesions and colorectal cancer

Dietary habits registry from participants: the dietary intake

时间窗: 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

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.

Gut microbiota profile

时间窗: 4 months

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.

次要结局

未报告次要终点

研究者

发起方
Fundación Vithas
申办方类型
Other
责任方
Sponsor

研究点 (1)

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