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Trial record 73 of 978 for:    colon cancer AND resection

Comparative Effectiveness of CTC & OC

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ClinicalTrials.gov Identifier: NCT02143115
Recruitment Status : Completed
First Posted : May 20, 2014
Last Update Posted : November 30, 2016
Sponsor:
Information provided by (Responsible Party):
Fox Chase Cancer Center

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.

Condition or disease Intervention/treatment
Colorectal Cancer Procedure: Optical colonoscopy Radiation: CT-Colonography

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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Study Type : Observational
Actual Enrollment : 244 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Comparative Effectiveness of Virtual and Optical Colonoscopy for Colorectal (CRC) Surveillance
Study Start Date : August 2011
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: Optical colonoscopy
    Examination of the colon with a colonoscope
  • Radiation: 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
    Other Name: CT-C or virtual colonoscopy


Primary Outcome Measures :
  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 [ Time Frame: One year post colorectal cancer resection ]
    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.


Secondary Outcome Measures :
  1. Compare the costs and outcomes of Computed Tomography Colonography versus independent Optical Colonoscopy plus Computed Tomography for post Colorectal Cancer resection surveillance. [ Time Frame: One year post colorectral cancer resection ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a history of colorectal cancer
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02143115


Locations
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United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, Wisconsin
University of Wisconsin-Madison
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Fox Chase Cancer Center
Investigators
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Principal Investigator: David S Weinberg, MD Fox Chase Cancer Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fox Chase Cancer Center
ClinicalTrials.gov Identifier: NCT02143115     History of Changes
Other Study ID Numbers: R01CA155347 ( U.S. NIH Grant/Contract )
First Posted: May 20, 2014    Key Record Dates
Last Update Posted: November 30, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Fox Chase Cancer Center:
Colorectal cancer surveillance

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases