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Inter-individual variation in susceptibility to colorectal neoplasia: the interaction between diet, DNA damage markers and genetic polymorphisms.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN41928225
Enrollment
Unknown
Registered
2004-01-23
Start date
1997-08-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal cancer Cancer Malignant neoplasm of other and ill-defined digestive organs

Interventions

The first arm involves volunteers common to both EPIC and Flexi-Scope studies. We shall study people with adenomatous polyps and matched controls only. The prospectively collected accurate dietary dat

Sponsors

NHS R&D Regional Programme Register - Department of Health (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: All people (male and female) randomised to the screening arm of the Flexi-scope Trial will be invited to participate in this study. General practioners are initially approached and if they agree to take part in the Flexi-Scope Trial all patients aged 55-64 are contacted by questionnaire to declare interest in that study.

Exclusion criteria

Exclusion criteria: 1. People unable to provide informed consent. 2. People with a history of colorectal cancer, adenomatous polyps or inflammatory bowel disease. 3. People with severe or terminal disease, with life expectancy of less than 5 years. 4. People with a recent history of sigmoidoscopy or colonoscopy (within 2 years). 5. People unfit for flexible sigmoidoscopy.

Design outcomes

Primary

MeasureTime frame
We shall perform cross-sectional and case-control analyses of the effect of diet and genetic polymorphisms on the prevalence of adenomatous and metaplastic polyps. Genetic polymorphisms will be examined in isolation and paired combinations and in groups stratified according to diet. We shall examine the effect of diet on MDA adduct rates (concentrating on foods relating to anti-oxidant status) and CBM adduct rates and k-ras mutations (concentrating on meat consumption and cooking methods) by categorical variables; and MDA and CBM adducts and k-ras mutation frequency in people with adenomatous polyps and polyp free controls (case-control). We shall examine the affect of ATase activity on any relationship found and ATase activity in people with adenomatous polyps and polyp free controls (case control). DNA will be stored for future analysis of as yet unrecognised polymorphisms which may be recognised as having a role in CRC. Samples taken from EPIC participants for adduct, ATase and k-ras measurement whose polyps are found to be metaplastic will be stored for possible future analysis: we shall investigate people with adenomatous polyps in the first instance as these are the precursors of colorectal cancer.

Secondary

MeasureTime frame
Not provided at time of registration

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026