Unprepped CT Colonography

February 10, 2010 updated by: Mayo Clinic

"CTC of the Unprepped Colon: Optimization & Validation"

It is our objective to improve the performance of CTC in the prepared colon, and to validate CTC in the unprepared colon for the detection of colorectal neoplasia. The cost-effectiveness ratio of CTC in the unprepared colon will compare favorably with other colorectal screening test.

Study Overview

Status

Completed

Conditions

Detailed Description

To improve the diagnostic performance of CTC in the prepared colon using improved spatial resolution, advanced image displays, and computer-assisted diagnosis, and to optimize diagnostic performance of CTC in the unprepared colon for colorectal polyp detection using electronic stool subtraction and computer-aided diagnostic techniques. To estimate the sensitivity and specificity of CTC in the unprepared colon for clinically important colorectal neoplasms (large adenomas ≥ 1 cm) and to compare such estimates with colonoscopy. To survey patient acceptance of CTC in the unprepared colon, and to assess implications for health care costs and cost-effectiveness of CTC in the unprepared colon in comparison with other approaches.

Study Type

Observational

Enrollment (Actual)

1255

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Mayo Clinic patients scheduled for colonoscopy.

Description

Inclusion Criteria:

Average risk or higher for colorectal cancer and scheduled for colonoscopy with any of the following indications:

  • Prior colorectal cancer, prior colorectal adenoma, strong family history of colorectal neoplasia, iron deficiency.
  • Age ≥ 40 -100 years
  • Known or highly suspected primary colorectal neoplasms > 10 mm (n = 160)
  • Higher than average risk for colorectal cancer and scheduled for colonoscopy with any of the following indications: prior colorectal cancer, prior colorectal adenoma, strong family history of colorectal neoplasia, iron deficiency.

Exclusion Criteria:

  • Less than 1/2 of colorectum remaining
  • Inflammatory bowel disease (Crohns, Chronic Ulcerative Colitis)
  • Familial Polyposis
  • Melena, hematochezia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
485 patients,who have an average risk (asymptomatic and without colon screening in the last 5 years) or those who have a high risk for colon cancer (strong family history of colon cancer or polyps and/or personal history of colon cancer or polyps).
2
160 patients, with a known colorectal lesion at or greater than 1 cm.
3
610 patients, who are of average risk for colon cancer (asymptomatic and no colon cancer screening in the last 5 years).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To optimize diagnostic performance of CTC in the unprepared colon for colorectal polyp detection using electronic stool subtraction and computer-aided diagnostic techniques.
Time Frame: 2000-2009
2000-2009

Secondary Outcome Measures

Outcome Measure
Time Frame
The cost-effectiveness ratio of CTC in the unprepared colon will compare favorably with other colorectal screening tests
Time Frame: 2000-2009
2000-2009

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: C. Daniel Johnson, M.D., Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2000

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

December 21, 2007

First Submitted That Met QC Criteria

January 3, 2008

First Posted (Estimate)

January 4, 2008

Study Record Updates

Last Update Posted (Estimate)

February 11, 2010

Last Update Submitted That Met QC Criteria

February 10, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1221-00
  • CA75333-08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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