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CompletedNCT02143115Updated Nov 30, 2016

Comparative Effectiveness of CTC & OC

An observational study in Colorectal Cancer, sponsored by Fox Chase Cancer Center. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-30.

Sponsored by Fox Chase Cancer Center · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
244
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Colorectal Cancer

Keywords

  • Colorectal cancer surveillance
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In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,458 are open to participants now.

This study's enrollment of 244 is close to the median of 250 across 1,226 observational studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Fox Chase Cancer Center is the lead sponsor of 211 studies on the registry; 30 are open to participants now.

Of its 15 completed or terminated interventional studies of FDA-regulated products, 8 (53%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with a history of colorectal cancer

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

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
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
244 participants (actual)
Patient registry
No

Interventions

  • ProcedureOptical colonoscopy

    Examination of the colon with a colonoscope

  • RadiationCT-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

    Also known as: CT-C or virtual colonoscopy

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What researchers measure

Primary outcomes

  1. 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

    To evaluate the test characteristics (sensitivity, specificity, positive and negative predictive value) of CT colonography (CT-C) for detecting colorectal adenomas and cancers in the post-CRC resection surveillance setting, using optical colonoscopy (OC) as the reference standard.

    Time frame: One year post colorectal cancer resection

Secondary outcomes

  1. Compare the costs and outcomes of Computed Tomography Colonography versus independent Optical Colonoscopy plus Computed Tomography for post Colorectal Cancer resection surveillance.

    Compare the costs and outcomes, from third party payor and societal perspectives, of CT-C versus independent OC plus CT for post CRC resection surveillance, using standard methods of cost-effectiveness analysis.

    Time frame: One year post colorectral cancer resection

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Study locations

5 sites
  • University of Chicago
    Chicago, Illinois 60637, United States
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
  • Memorial Sloan Kettering Cancer Center
    New York, New York 10065, United States
  • Fox Chase Cancer Center
    Philadelphia, Pennsylvania 19111, United States
  • University of Wisconsin-Madison
    Madison, Wisconsin 53792, United States
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References and documents

Publications

  • 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. PubMed 31531798 ↗
  • 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. PubMed 30338661 ↗
  • 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. PubMed 29174927 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 30, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02143115
Lead sponsor
Fox Chase Cancer Center
Responsible party
Sponsor
First posted
May 20, 2014
Start date
Aug 2011
Primary completion
Jun 2016
Completion
Jun 2016
Last update
Nov 30, 2016

Study contacts

David S Weinberg, MD
principal investigator · Fox Chase Cancer Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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