Colorectal PolypsNCT00204867
Virtual Colonoscopy (VC) for Primary Colorectal Screening
An observational study of Colorectal Polyps, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Colorectal Polyps
- What is being tested?
- CTC surveillance
- How many people
- 272 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Screening population for colorectal cancer
Who may be able to join
- Medium-sized colorectal polyps (6-9 mm)
Who cannot join
- No medium-sized colorectal polyps (6-9 mm)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Colorectal Polyps
- Being tested
- CTC surveillance
- Keywords
- colorectal, polyps
- Medical subject headings
- Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTC surveillanceOther
In vivo CTC surveillance of 6-9 mm polyp
| Study group | Role | What they receive |
|---|---|---|
| A | In vivo surveillance of 6-9 mm polyps detected at CTC Receives: Other: CTC surveillance |
What is being measured
The primary outcome is the main question the study is designed to answer.
The growth rate (natural history) of small colorectal polyps
Polyp growth rates are established by comparing polyp volume at the initial and surveillance CTC studies
Measured: The outcome measure of polyp growth rate is established at the time of surveillance CTC by comparing to the baseline CTC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJul 2004
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal PolypsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Naval Medical Center
- Responsible party
- Sponsor
- Investigators
- Perry J. Pickhardt, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00204867
- Sponsor's protocol ID
- 2004-0104
- Status last verified
- Jun 2016
- First submitted
- 13 Sep 2005
- Last updated
- 20 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23746988
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CT Virtual Colonoscopy for Primary Colorectal Screening
- ClinicalTrials.gov ID
- NCT00204867
- Acronym / sponsor ID
- 2004-0104
- Conditions
- Colorectal Polyps
- Keywords
- colorectal, polyps
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Naval Medical Center
- Study start
- Jul 2004
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | Other: CTC surveillanceIn vivo surveillance of 6-9 mm polyps detected at CTC |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Screening population for colorectal cancer
Key inclusion criteria (1 listed)
- Medium-sized colorectal polyps (6-9 mm)
Key exclusion criteria (1 listed)
- No medium-sized colorectal polyps (6-9 mm)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CTC surveillanceIn vivo CTC surveillance of 6-9 mm polyp | Other | A |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2016.
- Derived from this study: PubMed 23746988Pickhardt 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Perry J. Pickhardt, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Polyps, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00204867, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2016.