Diet, Genes and Colorectal Cancer - With Focus on Toll-like Receptor Polymorphisms

Completed

• Conditions: Colorectal Cancer
• Interventions: Other: Observational

• Registration Number: NCT03250637
• Lead Sponsor: University of Southern Denmark

Brief Summary

The aim of this study is to investigate the interaction between diet - primary meat and fiber - and polymorphisms in Toll-like receptors in relation to risk of colorectal cancer in a Danish prospective cohort.

Detailed Description

Meat and dietary fibers have been associated with increased and decreased risk of colorectal cancer (CRC), respectively. Toll-like receptors (TLRs) regulate intestinal immune response in a complex interplay between the mucosal epithelium and the microbiota and may therefore be important modulators of diet-induced CRC and interact with other inflammatory mediators.

The aim of the study is to investigate the association with functional TLR polymorphisms in relation to risk of CRC and their interaction with dietary factors. Additionally, interactions with previously studied polymorphisms in IL10, IL1B, PTGS2 and NFKB1 will be assessed in order to examine possible biological pathways in meat-induced CRC.

Data are retrieved from the Danish prospective "Diet, Cancer and Health" study encompassing 57,053 persons which were recruited between 1993 to 1997. Between 1994 and 31th December 2009, 1038 CRC cases has been diagnosed. A sub-cohort of 1857 persons has been randomly selected within the full cohort at time of entry into the cohort. The study design is a nested case-cohort study.

Study Timeline

• Study Start: 1993-12
• Primary Completion: 1997-05
• Study Completion: 2016-01
• Status Verified: 2017-08
• Study First Submitted: 2017-08-11
• Study First Submitted QC: 2017-08-14
• Last Update Submitted: 2017-08-14
• Study First Posted: 2017-08-15
• Last Update Posted: 2017-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2895

Inclusion Criteria

• Born in Denmark and had no previous cancers at study entry

Exclusion Criteria

• Previous or present cancer(s) at study entry

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sub-cohort members	Observational	1857 persons randomly selected within the full cohort at time of entry into the Diet, Cancer and Health cohort. These participants serve as controls for the colorectal cancer cases.
Colorectal cancer cases	Observational	1038 participants diagnosed with colorectal cancer from the Diet, Cancer and Health cohort.

Primary Outcome Measures

Name	Time	Method
Colorectal cancer	Between 1994 and 31th December 2009	Follow-up was based on population-based cancer registries