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Unprepped CT Colonography

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ClinicalTrials.gov Identifier: NCT00586053
Recruitment Status : Completed
First Posted : January 4, 2008
Last Update Posted : February 11, 2010
Sponsor:
Information provided by:
Mayo Clinic

Tracking Information
First Submitted Date December 21, 2007
First Posted Date January 4, 2008
Last Update Posted Date February 11, 2010
Study Start Date August 2000
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 3, 2008)
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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 3, 2008)
The cost-effectiveness ratio of CTC in the unprepared colon will compare favorably with other colorectal screening tests [ Time Frame: 2000-2009 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Unprepped CT Colonography
Official Title "CTC of the Unprepped Colon: Optimization & Validation"
Brief Summary 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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Mayo Clinic patients scheduled for colonoscopy.
Condition Colorectal Neoplasms
Intervention Not Provided
Study Groups/Cohorts
  • 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).
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 3, 2008)
1255
Original Estimated Enrollment Same as current
Actual Study Completion Date December 2009
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00586053
Other Study ID Numbers 1221-00
CA75333-08
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party C. Daniel Johnson, M.D., Mayo Clinic
Study Sponsor Mayo Clinic
Collaborators Not Provided
Investigators
Principal Investigator: C. Daniel Johnson, M.D. Mayo Clinic
PRS Account Mayo Clinic
Verification Date February 2010