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Screening and Risk Factors of Colon Neoplasia

NCT01647776 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 3315

Last updated 2021-02-09

No results posted yet for this study

Summary

The investigators propose a screening population-based study to systematically evaluate the accuracy and clinical relevance of sDNA testing as a potential alternative to colonoscopy screening. In addition, the investigators propose a genetic epidemiologic study of the relation between colon polyps, an established precursor of colon cancer, and two factors that may influence risk for colon cancer: candidate genes and diet.

Conditions

Interventions

OTHER

Stool DNA Test

Stool DNA test is done prior to the colonoscopy.

PROCEDURE

biopsies of rectal and colon mucosa

During the standard of care colonoscopy biopsies of rectal and colon mucosa will be taken for analysis of 15-PGDH pathway factors \[levels of prostaglandin E2 (PG E2), and mRNA for 15-PGDH, COX-1 and COX-2 expression\] as markers of risk of developing adenoma.

OTHER

Questionnaires

A Food Frequency Questionnaire (FFQ), a Meat Preparation Questionnaire (MPQ), and a Physical Activity Questionnaire (PAQ), all developed at the University of Arizona Cancer Center will be used to collect dietary and physical activity data. Risk Factor Questionnaire (RFQ) developed by the University of Southern California will be used to collect general risk information. Stool (sDNA) test patient satisfaction survey.

Sponsors & Collaborators

  • Case Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Joseph E Willis, MD · University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-04-01
Primary Completion
2015-08-11
Completion
2016-08-11

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01647776 on ClinicalTrials.gov