Efficacy of Fecal Immunochemical Test Using Digital Rectal Exam

Stopped early · Phase 1

Conditions studied: Fecal Immunochemical Test

In brief

This study will investigate the use of digital rectal exam (DRE) to obtain stool samples for the fecal immunochemical test (FIT) in patients due for screening colonoscopy and in pre-operative patients with known colorectal cancer. FIT is currently FDA-approved for spontaneous stool and DRE, however, samples are not commonly obtained by DRE. In addition, some clinicians remain skeptical about the accuracy of FIT using stool obtained from DRE. This study aims to assess the correlation between FIT using the stool sample from DRE (FIT-DRE) and standard of care FIT (FIT-SOC). If good correlation is shown, the investigators may be able to demonstrate efficacy of FIT using a DRE in the clinic setting. This may help avoid logistical barriers, as well as improve compliance and adherence to colon cancer screening in the outpatient setting, eventually leading to improved quality of care.

Key facts

Study ID

NCT03013855

Run by

Boston Medical Center

People needed

1

Starts

2016-07-01

Expected to finish

2017-07-01

Last updated by the study team

2017-07-31

Who can join

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

You may qualify if…

• Adults between the ages of 50-75 who are due for colon cancer screening and scheduled for colonoscopy
• Preoperative patients with established diagnosis of colon cancer

You may not qualify if…

• Patients with a diagnosis of Inflammatory Bowel Disease (IBD).
• Patients who are pregnant.

Where it is running

• Boston Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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