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A Follow-up Colonoscopy Examination in Patients Who Had Previously Undergone Screening Colonoscopy
This study has been completed.
Sponsored by: Chinese University of Hong Kong
Information provided by: Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT00280332
  Purpose
  • 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

Condition Intervention
Colonic Cancer
Procedure: colonoscopy

MedlinePlus related topics: Cancer
U.S. FDA Resources
Study Type: Observational
Study Design: Case Control, Prospective
Official Title: A Follow-up Colonoscopy Examination in Patients Who Had Previously Undergone Screening Colonoscopy

Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • The prevalence of advanced colonic adenoma in the re-screening population [ Time Frame: 5 year from index colonoscopy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The time to adenoma adenoma development according to different baseline characteristics of patients and colonoscopy findings [ Time Frame: 5 years from index colonoscopy ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Enrollment: 560
Study Start Date: March 2006
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A
colonic adenoma
Procedure: colonoscopy
proform a follow up colonoscopy in the 5 year period from index colonoscopy
B
colonic without adenoma
Procedure: colonoscopy
proform a follow up colonoscopy in the 5 year period from index colonoscopy

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.

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00280332

Locations
China
Endoscopy Center, Prince of Wales Hospital
Hong Kong (SAR), China
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Wai K Leung, MD CUHK
  More Information

Responsible Party: Chinese University of Hong Kong ( Dr WK Leung )
Study ID Numbers: FUC
Study First Received: January 20, 2006
Last Updated: May 9, 2008
ClinicalTrials.gov Identifier: NCT00280332  
Health Authority: Hong Kong: Department of Health

Keywords provided by Chinese University of Hong Kong:
colonic adenoma, colonic advanced neoplasm

Study placed in the following topic categories:
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Colonic Neoplasms
Adenoma
Intestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 15, 2009