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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
History of Changes
  Purpose

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.


Condition
Colorectal Neoplasms

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: "CTC of the Unprepped Colon: Optimization & Validation"

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1255
Study Start Date: August 2000
Study Completion Date: December 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
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).

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Mayo Clinic patients scheduled for colonoscopy.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00586053

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: C. Daniel Johnson, M.D. Mayo Clinic
  More Information

Publications:

Responsible Party: C. Daniel Johnson, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00586053     History of Changes
Other Study ID Numbers: 1221-00, CA75333-08
Study First Received: December 21, 2007
Last Updated: February 10, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
Colonic Polyps
Colon
Large Intestine
Cecum
Sigmoid
Rectum
 Colonoscopy
Virtual Colonoscopy
CT Colonography
Computed Tomographic Colonography
Colonography

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

ClinicalTrials.gov processed this record on May 23, 2013