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Unprepped CT Colonography

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00586053
First received: December 21, 2007
Last updated: February 10, 2010
Last verified: February 2010

December 21, 2007
February 10, 2010
August 2000
December 2008   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00586053 on ClinicalTrials.gov Archive Site
The cost-effectiveness ratio of CTC in the unprepared colon will compare favorably with other colorectal screening tests [ Time Frame: 2000-2009 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Unprepped CT Colonography
"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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Mayo Clinic patients scheduled for colonoscopy.

Colorectal Neoplasms
Not Provided
  • 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).

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1255
December 2009
December 2008   (final data collection date for primary outcome measure)

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
Both
40 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00586053
1221-00, CA75333-08
No
C. Daniel Johnson, M.D., Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: C. Daniel Johnson, M.D. Mayo Clinic
Mayo Clinic
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP