Virtual Colonoscopy (VC) for Primary Colorectal Screening

This study has been completed.
Sponsor:
Collaborator:
National Naval Medical Center
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00204867
First received: September 13, 2005
Last updated: June 17, 2016
Last verified: June 2016

September 13, 2005
June 17, 2016
July 2004
June 2016   (final data collection date for primary outcome measure)
The growth rate (natural history) of small colorectal polyps [ Time Frame: The outcome measure of polyp growth rate is established at the time of surveillance CTC by comparing to the baseline CTC ] [ Designated as safety issue: No ]
Polyp growth rates are established by comparing polyp volume at the initial and surveillance CTC studies
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Complete list of historical versions of study NCT00204867 on ClinicalTrials.gov Archive Site
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Virtual Colonoscopy (VC) for Primary Colorectal Screening
CT Virtual Colonoscopy for Primary Colorectal Screening
This study involves a primary VC screening for colorectal polyps. The research hypothesis is that VC screening, including surveillance of sub-cm polyps, is a safe and effective approach.
The purpose of this study is to use virtual colonoscopy screening to learn more about what happens to small colon polyps (less than 10 mm) over time. From this, we can find out whether it's safer to remove all colon polyps right away or leave the small ones in place and remove only those that grow to 10 mm or more.
Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample
Screening population for colorectal cancer
Colorectal Polyps
Other: CTC surveillance
In vivo CTC surveillance of 6-9 mm polyp
A
In vivo surveillance of 6-9 mm polyps detected at CTC
Intervention: Other: CTC surveillance
Pickhardt PJ, Kim DH, Pooler BD, Hinshaw JL, Barlow D, Jensen D, Reichelderfer M, Cash BD. Assessment of volumetric growth rates of small colorectal polyps with CT colonography: a longitudinal study of natural history. Lancet Oncol. 2013 Jul;14(8):711-20. doi: 10.1016/S1470-2045(13)70216-X. Epub 2013 Jun 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
272
June 2016
June 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Medium-sized colorectal polyps (6-9 mm)

Exclusion Criteria:

  • No medium-sized colorectal polyps (6-9 mm)
Both
50 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00204867
2004-0104
Yes
Not Provided
Not Provided
University of Wisconsin, Madison
University of Wisconsin, Madison
National Naval Medical Center
Principal Investigator: Perry J. Pickhardt, MD University of Wisconsin, Madison
University of Wisconsin, Madison
June 2016

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