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Virtual Colonoscopy (VC) for Primary Colorectal Screening

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00204867
First Posted: September 20, 2005
Last Update Posted: June 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Naval Medical Center
Information provided by (Responsible Party):
University of Wisconsin, Madison
  Purpose
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 ]
    Polyp growth rates are established by comparing polyp volume at the initial and surveillance CTC studies


Enrollment: 272
Study Start Date: July 2004
Study Completion Date: June 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Screening population for colorectal cancer
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • No medium-sized colorectal polyps (6-9 mm)
  Contacts and Locations
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): NCT00204867


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00204867     History of Changes
Other Study ID Numbers: 2004-0104
First Submitted: September 13, 2005
First Posted: September 20, 2005
Last Update Posted: June 20, 2016
Last Verified: June 2016

Keywords provided by University of Wisconsin, Madison:
colorectal
polyps