Impact of DietarY and LIfestyle Risk Factors on Colorectal Cancer Screening

NCT02804802 | Unknown DMC

• 1 other identifier: PHRC-K 2011
• Study Type: observational
• Target: 49,000
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of our project is to construct a lifestyle score based on a short questionnaire easy to complete and to validate it among participants in mass screening for colorectal cancer in Maine and Loire department over the next 2 years (2012 and 2013). We will evaluate the ability of our score to identify subjects with colorectal cancer diagnosed by the screening procedure (Hemoccult II ®, and colonoscopy if the test result is positive). Colorectal cancer will be the primary outcome for the assessment of the score's performance. The secondary endpoint will focus on colorectal adenomas diagnosed by the same procedure. Our secondary objectives are to test a second weighting system, evaluate the benefit in terms of predictive performance to add to the lifestyle score other dietary factors among that have a probable link with the risk of colorectal cancer, determine the acceptability of the questionnaire and to estimate by a cost-utility analysis the impact of applying a strategy of targeted screening using the developed score.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Colorectal cancer diagnosed by colonoscopy after a positive fecal occult blood test (Hemoccult II)

  1 year

Interventions

questionnaire OTHER

dietary habits and physical activity questionnaire

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All participants in the organized screening for colorectal cancer over the next 2 years in the Maine-et-Loire department.

You may qualify if:

• All participants in the organized screening for colorectal cancer over the next 2 years in the Maine-et-Loire department.

You may not qualify if:

• Personal or family history of polyps or colorectal cancer
• Personal history of bowel disease that already implies a surveillance by colonoscopy (inflammatory bowel syndrome, HNPCC, FAP)
• Diseases with known genetic risk of developing colorectal cancer

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

François-Xavier CAROLI-BOSC

Angers, France

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• François-Xavier Caroli-Bosc, MD PhD

  UH Angers

  PRINCIPAL INVESTIGATOR

Central Study Contacts

François-Xavier Caroli-Bosc, MD PhD

CONTACT

+33241356054; FXCaroli-Bosc@chu-angers.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2016
• First Posted: June 17, 2016
• Study Start: February 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: September 1, 2016
• Last Updated: June 24, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)