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OpenTrials
Completed

NCT Number: NCT00586053

Unprepped CT Colonography

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  1. The cost-effectiveness ratio of CTC in the unprepared colon will compare favorably with other colorectal screening tests

    Time frame: 2000-2009

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

"CTC of the Unprepped Colon: Optimization & Validation"

Important dates

Study start
2000
Primary completion
2008
Study completion
2009
First posted
Jan 4, 2008
Registry last updated
Feb 11, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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