Effect of a Tracking Program on Colon Adenoma Surveillanc... | NCT01713881

Studies
Effect of a Tracking Program on Colon Adenoma Surveillance and Adherence to Guideline Recommendations

NCT01713881

Sponsor

United States Department of Defense

Status

Unknown status

Last Update Posted

Mar 20, 2014Estimated

Enrollment

500Estimated

Phase

Not provided

Conditions

Colon Polyp Surveillance

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2012

Primary Completion Date

Dec 2013Actual

Completion Date

Jun 2014Estimated

First Submitted Date

Oct 23, 2012

First Submission Date that Met QC Criteria

Oct 23, 2012

First Posted Date

Oct 25, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 19, 2014

Last Update Posted Date

Mar 20, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

R. Keith Fincher, MD, FACP, FACG, Gastroenterologist, United States Department of DefensePrincipal Investigator

Lead Sponsor

United States Department of DefenseFED

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This will be a retrospective chart review of 880-1000 patients who had a colonoscopy and were found to have a tubular adenoma between the years of 2004-2008. We will compare the rate and timing of completion of repeat colonoscopies pre and post establishment of a polyp registry (tracking system) in 2006. Each group will be composed of up to 500 subjects consecutively identified from all the patients who underwent colonoscopy and were found to have a tubular adenoma (Group 1-2004 to 2006, Group 2 2007-2008).

Detailed Description

This will be a retrospective chart review of 880-1000 patients who had a colonoscopy and were found to have a tubular adenoma between the years of 2004-2008. We will compare the rate and timing of completion of repeat colonoscopies pre and post establishment of a polyp registry (tracking system) in 2006. Each group will be composed of 380-500 subjects consecutively identified from all the patients who underwent colonoscopy and were found to have a tubular adenoma (Group 1-2004 to 2006, Group 2 2007-2008).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
post-registry		Registry Group: Select 500 consecutive patients from the polyp registry who were found to have a tubular adenoma on a colonoscopy done between 2007-2008 from the polyp registry. Quantify the completion rate and time between index and surveillance colonoscopy after the establishment of the polyp surveillance program (2006-2013).
pre-registry		Pre-registry Group: Select 380 consecutive patients who were found to have a tubular adenoma on a colonoscopy done between April 2004-Nov 2006.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage completing follow up colonoscopy	A polyp tracking program (registry) decreases the amount of patients lost to follow up.	12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Any adenoma found on screening/surveillance colonoscopy (ICD9-211.3, Procedure code 45385 or 45380)
Greater than 18 years old

Exclusion Criteria:

Less than 18 years old
Diagnosis of IBD

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with colon polyps

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
D.D. Eisenhower Army Medical Center		Fort Gordon	Georgia	30905	United States

Condition Browse Module

MeSH Terms

ID	Term
D011127	Polyps

Ancestor Terms

ID	Term
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

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Browse Branches

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