A Follow-up Colonoscopy Examination in Patients Who Had P... | NCT00280332

Studies
A Follow-up Colonoscopy Examination in Patients Who Had Previously Undergone Screening Colonoscopy

NCT00280332

Sponsor

Chinese University of Hong Kong

Status

Completed

Last Update Posted

May 12, 2008Estimated

Enrollment

560Actual

Phase

Not provided

Conditions

Colonic Cancer

Interventions

colonoscopy

Countries

China

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

May 2008

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

Mar 2006

Primary Completion Date

Nov 2007Actual

Completion Date

Nov 2007Actual

First Submitted Date

Jan 20, 2006

First Submission Date that Met QC Criteria

Jan 20, 2006

First Posted Date

Jan 23, 2006Estimated

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

May 9, 2008

Last Update Posted Date

May 12, 2008Estimated

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

To determine the prevalence of colonic neoplasm in patients who had previously undergone screening colonoscopy
To determine the optimal time interval for re-screening in average risk individuals
To determine potential baseline characteristics that predicts adenoma recurrence

Detailed Description

Colorectal cancer (CRC) is the second commonest cancer in Hong Kong, and tends to be increasing. Screening for colorectal cancer can reduce the cancer incidence and mortality by detecting early lesions. However, the best interval for a follow up colonoscopy, particularly for those with normal baseline colonoscopy, remains largely unknown.

This study aim to determine the prevalence of colonic neoplasm in average-risk patients who had previously undergone screening colonoscopy and the optimal time interval for re-screening.

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

560Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A		colonic adenoma	Procedure: colonoscopy
B		colonic without adenoma	Procedure: colonoscopy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
colonoscopy	Procedure	proform a follow up colonoscopy in the 5 year period from index colonoscopy	A B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The prevalence of advanced colonic adenoma in the re-screening population		5 year from index colonoscopy

Secondary Outcomes

Measure	Description	Time Frame
The time to adenoma adenoma development according to different baseline characteristics of patients and colonoscopy findings		5 years from index colonoscopy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects who are previously participated in one of our two screening colonoscopy studies [Sung, Gastroenterol 2003; Leung, AJG 2004]
Asymptomatic on first screening colonoscopy
Age>50and <75
No family history of CRC
No other colonoscopy except the baseline screening colonoscopy

Exclusion Criteria:

Subjects who refused consent
Subjects who are not warrant follow up colonoscopy

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Subjects who are previously participated in one of our two screening colonoscopy studies [Sung, Gastroenterol 2003; Leung, AJG 2004]

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wai K Leung, MD	CUHK	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Endoscopy Center, Prince of Wales Hospital		Hong Kong (sar)			China

Condition Browse Module

MeSH Terms

ID	Term
D003110	Colonic Neoplasms

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

Intervention Browse Module

MeSH Terms

ID	Term
D003113	Colonoscopy

Ancestor Terms

ID	Term
D016099	Endoscopy, Gastrointestinal
D016145	Endoscopy, Digestive System
D003938	Diagnostic Techniques, Digestive System
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided