Virtual Colonoscopy (VC) for Primary Colorectal Screening
June 17, 2016 updated by: University of Wisconsin, Madison
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.
Study Overview
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.
Study Type
Observational
Enrollment (Actual)
272
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Wisconsin
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Madison, Wisconsin, United States, 53792
- University of Wisconsin
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Screening population for colorectal cancer
Description
Inclusion Criteria:
- Medium-sized colorectal polyps (6-9 mm)
Exclusion Criteria:
- No medium-sized colorectal polyps (6-9 mm)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
A
In vivo surveillance of 6-9 mm polyps detected at CTC
|
In vivo CTC surveillance of 6-9 mm polyp
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
The outcome measure of polyp growth rate is established at the time of surveillance CTC by comparing to the baseline CTC
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Perry J. Pickhardt, MD, University of Wisconsin, Madison
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2004
Primary Completion (Actual)
June 1, 2016
Study Completion (Actual)
June 1, 2016
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 20, 2005
Study Record Updates
Last Update Posted (Estimate)
June 20, 2016
Last Update Submitted That Met QC Criteria
June 17, 2016
Last Verified
June 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2004-0104
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.