NCT00280332

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
560

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2006

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

First Submitted

Initial submission to the registry

January 20, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 23, 2006

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2006

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

May 12, 2008

Status Verified

May 1, 2008

Enrollment Period

1.7 years

First QC Date

January 20, 2006

Last Update Submit

May 9, 2008

Conditions

Keywords

colonic adenoma, colonic advanced neoplasm

Outcome Measures

Primary Outcomes (1)

  • The prevalence of advanced colonic adenoma in the re-screening population

    5 year from index colonoscopy

Secondary Outcomes (1)

  • The time to adenoma adenoma development according to different baseline characteristics of patients and colonoscopy findings

    5 years from index colonoscopy

Study Arms (2)

A

colonic adenoma

Procedure: colonoscopy

B

colonic without adenoma

Procedure: colonoscopy

Interventions

colonoscopyPROCEDURE

proform a follow up colonoscopy in the 5 year period from index colonoscopy

Also known as: follow up colonoscopy
AB

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Endoscopy Center, Prince of Wales Hospital

Hong Kong (sar), China

Location

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Wai K Leung, MD

    CUHK

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 20, 2006

First Posted

January 23, 2006

Study Start

March 1, 2006

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

May 12, 2008

Record last verified: 2008-05

Locations