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

NCT ID: NCT03250637

Last Updated: 2017-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

2895 participants

Study Classification

OBSERVATIONAL

Study Start Date

1993-12-31

Study Completion Date

2016-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colorectal Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Colorectal cancer cases

1038 participants diagnosed with colorectal cancer from the Diet, Cancer and Health cohort.

Observational

Intervention Type OTHER

Information on diet, lifestyle, weight, height, medical treatment, environmental exposures, and other socio-economic factors were collected at enrolment using questionnaires and interviews

Sub-cohort members

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.

Observational

Intervention Type OTHER

Information on diet, lifestyle, weight, height, medical treatment, environmental exposures, and other socio-economic factors were collected at enrolment using questionnaires and interviews

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Observational

Information on diet, lifestyle, weight, height, medical treatment, environmental exposures, and other socio-economic factors were collected at enrolment using questionnaires and interviews

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* Previous or present cancer(s) at study entry
Minimum Eligible Age

50 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Danish Cancer Society

OTHER

Sponsor Role collaborator

University of Southern Denmark

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Vibeke Andersen

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Vibeke Andersen, MD, PhD

Role: STUDY_DIRECTOR

University of Southern Denmark

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 17786808 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29566186 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

19-TLR

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.