NCT00204867

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
272

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
10.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

June 20, 2016

Status Verified

June 1, 2016

Enrollment Period

11.9 years

First QC Date

September 13, 2005

Last Update Submit

June 17, 2016

Conditions

Colorectal Polyps

Keywords

colorectalpolyps

Outcome Measures

Primary Outcomes (1)

  • 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

    The outcome measure of polyp growth rate is established at the time of surveillance CTC by comparing to the baseline CTC

Study Arms (1)

A

In vivo surveillance of 6-9 mm polyps detected at CTC

Other: CTC surveillance

Interventions

CTC surveillanceOTHER

In vivo CTC surveillance of 6-9 mm polyp

A

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Screening population for colorectal cancer

You may qualify if:

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

You may not qualify if:

  • No medium-sized colorectal polyps (6-9 mm)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Related Publications (1)

  • 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.

    PMID: 23746988DERIVED

MeSH Terms

Conditions

Polyps

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Perry J. Pickhardt, MD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

July 1, 2004

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

June 20, 2016

Record last verified: 2016-06

Locations

US(1)