Clinical Trials Directory

Trials / Completed

CompletedNCT02143115

Comparative Effectiveness of CTC & OC

Comparative Effectiveness of Virtual and Optical Colonoscopy for Colorectal (CRC) Surveillance

Status
Completed
Phase
Study type
Observational
Enrollment
244 (actual)
Sponsor
Fox Chase Cancer Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The goal of this study is to compare the findings of virtual (CT-colonography) with findings of optical colonoscopies to determine if virtual colonoscopy is suitable for colorectal cancer surveillance.

Detailed description

The goal of this study is to compare, both clinically and from a cost-effectiveness perspective, virtual or CT-C (CT-Colonography) to standard CT scan and optical colonoscopy (OC). Virtual colonoscopy is a combination of a radiologic evaluation of the abdomen and pelvis with intra-colonic imaging. Previous research supports the concept that CT-C may be an effective substitute for the current OC and address limited compliance for surveillance for CRC survivors. Post-operative CRC surveillance strategies are effective, but depend upon patient compliance which is less than desired. Improved adherence is linked with greater cost-effectiveness as well as better clinical outcomes. CT-C possesses potential advantages: convenience as a single test, less risk, possibly patient preference and lower total costs. Costs would be reduced through direct (provision of fewer optical colonoscopies) and indirect means (reduction in time lost from work by patient and chaperone, etc.). When extrapolated across the roughly 200,000 OCs performed annually in the US for this indication reduced utilization of even 50% in a high unit cost procedure like OC would yield substantial savings without a reduction in clinical quality.

Conditions

Interventions

TypeNameDescription
PROCEDUREOptical colonoscopyExamination of the colon with a colonoscope
RADIATIONCT-ColonographyA computerized X-ray that may find out if there are polyps or cancers and also pictures the contents of the abdomen and pelvis

Timeline

Start date
2011-08-01
Primary completion
2016-06-01
Completion
2016-06-01
First posted
2014-05-20
Last updated
2016-11-30

Locations

5 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT02143115. Inclusion in this directory is not an endorsement.