Virtual Colonoscopy (VC) for Primary Colorectal Screening

This study is ongoing, but not recruiting participants.
National Naval Medical Center
Information provided by (Responsible Party):
University of Wisconsin, Madison Identifier:
First received: September 13, 2005
Last updated: December 5, 2014
Last verified: December 2014
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.

Condition Intervention
Colorectal Polyps
Other: CTC surveillance

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: CT Virtual Colonoscopy for Primary Colorectal Screening

Resource links provided by NLM:

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • 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

Estimated Enrollment: 1000
Study Start Date: July 2004
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
In vivo surveillance of 6-9 mm polyps detected at CTC
Other: CTC surveillance
In vivo CTC surveillance of 6-9 mm polyp

Detailed Description:
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.

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Screening population for colorectal cancer

Inclusion Criteria:

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

Exclusion Criteria:

  • No medium-sized colorectal polyps (6-9 mm)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00204867

United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
National Naval Medical Center
Principal Investigator: Perry J. Pickhardt, MD University of Wisconsin, Madison
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Wisconsin, Madison Identifier: NCT00204867     History of Changes
Other Study ID Numbers: 2004-0104 
Study First Received: September 13, 2005
Last Updated: December 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
polyps processed this record on May 04, 2016