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Comparative Effectiveness of CTC & OC

NCT ID: NCT02143115

Last Updated: 2016-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

244 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-08-31

Study Completion Date

2016-06-30

Brief Summary

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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

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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

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Colorectal Cancer

Keywords

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Colorectal cancer surveillance

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Optical colonoscopy

Examination of the colon with a colonoscope

Intervention Type PROCEDURE

CT-Colonography

A computerized X-ray that may find out if there are polyps or cancers and also pictures the contents of the abdomen and pelvis

Intervention Type RADIATION

Other Intervention Names

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CT-C or virtual colonoscopy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fox Chase Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David S Weinberg, MD

Role: PRINCIPAL_INVESTIGATOR

Fox Chase Cancer Center

Locations

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University of Chicago

Chicago, Illinois, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

University of Wisconsin-Madison

Madison, Wisconsin, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 31531798 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30338661 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29174927 (View on PubMed)

Other Identifiers

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R01CA155347

Identifier Type: NIH

Identifier Source: org_study_id

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