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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

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.

Condition or disease
Colorectal Neoplasms

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
Actual Enrollment : 1255 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: "CTC of the Unprepped Colon: Optimization & Validation"
Study Start Date : August 2000
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2009

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).



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. The cost-effectiveness ratio of CTC in the unprepared colon will compare favorably with other colorectal screening tests [ Time Frame: 2000-2009 ]


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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): 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

Publications of Results:
Responsible Party: C. Daniel Johnson, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00586053     History of Changes
Other Study ID Numbers: 1221-00
CA75333-08
First Posted: January 4, 2008    Key Record Dates
Last Update Posted: February 11, 2010
Last Verified: February 2010

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:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases