Chromocolonoscopy for the Detection of Flat Adenomas in R... | NCT00245492

Studies
Chromocolonoscopy for the Detection of Flat Adenomas in Routine Colorectal Cancer Screening.

NCT00245492

Sponsor

Indiana University

Status

Completed

Last Update Posted

Jan 28, 2009Estimated

Enrollment

792Estimated

Phase

Not Applicable

Conditions

Colon Cancer
Polyp
Adenoma

Interventions

Chromocolonoscopy

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

ID	Type	Description	Link
2005ACG-100CRC

Status Module

Record Verification Date

Jan 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2006

Primary Completion Date

Dec 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Oct 26, 2005

First Submission Date that Met QC Criteria

Oct 26, 2005

First Posted Date

Oct 28, 2005Estimated

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

Jan 27, 2009

Last Update Posted Date

Jan 28, 2009Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Indiana UniversityOTHER

Collaborators

Name	Class
American College of Gastroenterology	OTHER
Stony Brook University	OTHER
University of Chicago	OTHER

Description Module

Brief Summary

The proposed research aims to determine the prevalence, size, shape and histology of flat colorectal neoplasms in a cohort of asymptomatic, average-risk individuals presenting for screening colonoscopy. Patients will be randomized to either conventional colonoscopy or chromocolonoscopy, where the entire colon will be sprayed with indigocarmine dye and examined in the usual manner. The primary outcome will be the total number of adenomas detected, with special attention to the subgroup of flat and depressed lesions. To promote the generalizability of the results, neoplasms will be described according to standard Western and Japanese classification schemes.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

792Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Chromocolonoscopy	Procedure: Chromocolonoscopy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Chromocolonoscopy	Procedure	Indigocarmine dye applied to entire colon to highlight mucosal detail and enhance detection of flat lesions.	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevalence of adenomas detected by chromocolonoscopy versus standard colonoscopy.		Cross-sectional prevalence of adenomas between the 2 study groups

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing screening colonoscopy

Exclusion Criteria:

Age < 50
Prior colon resection
Inflammatory bowel disease
Prior colonoscopy or sigmoidoscopy
More than one first-degree relative with colon cancer

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Charles J Kahi, MD	Indiana University School of Medicine, Roudebush VA Medical Center, Indianapolis, Indiana	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Indiana University		Indianapolis	Indiana	46202	United States
Roudebush VA Medical Center

Condition Browse Module

MeSH Terms

ID	Term
D003110	Colonic Neoplasms
D011127	Polyps
D000236	Adenoma

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided