Study of In-home Tests for Colorectal Cancer

Completed · Not applicable

Conditions studied: Colorectal Cancer

In brief

The objective of this study is to compare the performance characteristics or accuracy of different in-home screening tests for colorectal cancer (fecal occult blood tests), among patients without symptoms of colorectal cancer. Patients who meet study eligibility criteria and agree to participate in the study are asked to perform one guaiac and two immunochemical fecal occult blood tests at home prior to their colonoscopy. After the patient has completed and sent in the test kits, the patient then undergoes their previously scheduled colonoscopy. Accuracy and performance characteristics for each type of fecal occult blood test, including sensitivity, specificity, test positivity rate and positive predictive value for advanced colorectal neoplasia (advanced colorectal polyps) or colorectal cancer, will be estimated by comparing the fecal occult blood test results with the results of the colonoscopy.

Key facts

Study ID

NCT01998009

Run by

Centers for Disease Control and Prevention

People needed

1382

Starts

2011-05-01

Expected to finish

2014-09-01

Last updated by the study team

2015-02-05

Who can join

Age: 50 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 50 - 75 years of age
• Scheduled to have a colonoscopy for screening or as a routine exam
• Has not had more than one episode of rectal bleeding in the last 6 months
• Does not have a personal history of colorectal cancer or colorectal polyps
• Has not had a positive FOBT in the 12 months prior to study enrollment
• Has not had a colonoscopy within the past 5 years
• Has not had a prior colon resection or colon or rectal surgery
• Does not have a history of inflammatory bowel disease (e.g. ulcerative colitis or Crohn's disease)
• Does not have a personal or family history of familial adenomatous polyposis (FAP) or hereditary nonpolyposis colorectal cancer (HNPCC)
• Not currently taking anticoagulant medication such as Coumadin, Warfarin, Heparin, or Plavix
• Able to read English

Where it is running

• Indiana University — Indianapolis, Indiana, United States
• University of Minnesota — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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