Clinical trial NCT02143115: Comparative Effectiveness of CTC & OC
Official title: Comparative Effectiveness of Virtual and Optical Colonoscopy for Colorectal (CRC) Surveillance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Keywords: Colorectal cancer surveillance
Lead sponsor: Fox Chase Cancer Center
Sponsor class: OTHER
First posted: 2014-05-20
Enrollment: 244
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a history of colorectal cancer

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Patients with a history of CRC without clear evidence of metastatic disease who have completed their acute cancer-specific treatment
* Patients aged 18 years or older
* Patients who have signed an approved informed consent form

Exclusion Criteria:

* Patients with a diverting ileostomy, with a history of inflammatory bowel disease, FAP, or active GI symptoms (gastrointestinal bleed, diarrhea, severe abdominal pain, etc.)
* Patients who are pregnant

Primary outcomes:
measure: Compare the test characteristics (sensitivity, specificity, positive and negative predictive value) of Computed Tomography colonography (CT-C) in the post Colorectal cancer resection using optical colonoscopy as the reference standard
timeFrame: One year post colorectal cancer resection
Secondary outcomes:
measure: Compare the costs and outcomes of Computed Tomography Colonography versus independent Optical Colonoscopy plus Computed Tomography for post Colorectal Cancer resection surveillance.
timeFrame: One year post colorectral cancer resection
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Madison
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
Study officials:
affiliation: Fox Chase Cancer Center
name: David S Weinberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weinberg DS, Mitnick J, Keenan E, Li T, Ross EA. Post-operative colorectal cancer surveillance: preference for optical colonoscopy over computerized tomographic colonography. Cancer Causes Control. 2019 Nov;30(11):1269-1273. doi: 10.1007/s10552-019-01231-w. Epub 2019 Sep 17.
citation: Kupfer SS, Lubner S, Coronel E, Pickhardt PJ, Tipping M, Graffy P, Keenan E, Ross E, Li T, Weinberg DS. Adherence to postresection colorectal cancer surveillance at National Cancer Institute-designated Comprehensive Cancer Centers. Cancer Med. 2018 Nov;7(11):5351-5358. doi: 10.1002/cam4.1678. Epub 2018 Oct 18.
citation: Weinberg DS, Pickhardt PJ, Bruining DH, Edwards K, Fletcher JG, Gollub MJ, Keenan EM, Kupfer SS, Li T, Lubner SJ, Markowitz AJ, Ross EA. Computed Tomography Colonography vs Colonoscopy for Colorectal Cancer Surveillance After Surgery. Gastroenterology. 2018 Mar;154(4):927-934.e4. doi: 10.1053/j.gastro.2017.11.025. Epub 2017 Nov 22.