Clinical trial NCT03250637: Diet, Genes and Colorectal Cancer - With Focus on Toll-like Receptor Polymorphisms
Official title: Meat and Fiber Intake and Interaction With Pattern Recognition Receptors (TLR1, TLR2, TLR4, and TLR10) in Relation to Colorectal Cancer in a Danish Prospective, Case-cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Keywords: Gene-environment interaction
Candidate gene
Western style diet
Toll-like receptors
Prospective study
Nested case-cohort
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Danish Cancer Society
First posted: 2017-08-15
Enrollment: 2895
Sex: ALL
Minimum age (years): 50
Maximum age (years): 64
Standard ages: ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The Diet, Cancer and Health study is an ongoing Danish cohort study designed to investigate the relation between diet, lifestyle and cancer risk. The cohort consists of 57,053 persons, recruited between December 1993 and May 1997. All the subjects were born in Denmark, and the individuals were 50 to 64 years of age and had no previous cancers at study entry. Blood samples, anthropometric measures and questionnaire data on diet and lifestyle were collected at study entry.

The present study uses a nested case-cohort design. Follow-up is based on population-based cancer registries. Between 1994 and 31th December 2009, 1038 CRC cases were diagnosed. A sub-cohort of 1857 persons has randomly been selected within the full cohort at time of entry into the cohort.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Previous or present cancer(s) at study entry

Primary outcomes:
measure: Colorectal cancer
timeFrame: Between 1994 and 31th December 2009
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Southern Denmark
name: Vibeke Andersen, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Tjonneland A, Olsen A, Boll K, Stripp C, Christensen J, Engholm G, Overvad K. Study design, exposure variables, and socioeconomic determinants of participation in Diet, Cancer and Health: a population-based prospective cohort study of 57,053 men and women in Denmark. Scand J Public Health. 2007;35(4):432-41. doi: 10.1080/14034940601047986.
citation: Kopp TI, Vogel U, Tjonneland A, Andersen V. Meat and fiber intake and interaction with pattern recognition receptors (TLR1, TLR2, TLR4, and TLR10) in relation to colorectal cancer in a Danish prospective, case-cohort study. Am J Clin Nutr. 2018 Mar 1;107(3):465-479. doi: 10.1093/ajcn/nqx011.