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Effectiveness of Fecal Immunnochemical Test and Colonoscopy Screening in Hong Kong

NCT03597204 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15000

Last updated 2025-07-23

No results posted yet for this study

Summary

Colorectal neoplasm in Asia is now increasingly common and is rising in an alarming manner in Hong Kong. Population-based screening for colorectal cancer (CRC) should be implemented. With the establishment of the CUHK JC Bowel Cancer Education Centre in 2008, about 10,000 asymptomatic subjects aged 50-70 years have completed screening by either faeca immunochemical test (FIT)or colonoscopy till December 2012. From 2013 onwards, the centre invites subjects aged 40-70 years with risk factors for CRC to undergo screening by FIT on a yearly basis. If FIT result is positive, according to local practice, they will be offered a routine colonoscopy as they will be treated as symptomatic. Currently, about 2,500 subjects have received CRC screening in this new project. There will be 2,500 subjects more to be recruited to this till 31 December 2017. The investigators would like to carry out a prospective cohort study of these 2,500 subjects and also retrospectively review the cohort of 12,500 subjects who received CRC screening in the CUHK JC Bowel Cancer Education Centre.

The present study aims to:

1. . Evaluate the knowledge, attitude, perception, practice, perceived obstacles and changes in choice of CRC screening among the screening participants;
2. . Assess the levels of compliance across time among those who joined the screening programme, according to different subject characteristics;
3. . Explore the diagnostic accuracy of faecal immunochemical tests among subjects with different characteristics;
4. . Evaluate the risk factors for colorectal neoplasia and if applicable, devise and validate a risk scoring system for prediction of neoplasia in different colon sites;
5. . Evaluate the association between bowel preparation, colonoscopy withdrawal time and adenoma detection rate among those who received colonoscopy;
6. . Validation of the existing risk scoring systems for colorectal neoplasia from the literature, based on findings from subjects who received colonoscopy.
7. . Explore potential associations among colorectal neoplasia detected in different colon sites.

Conditions

Interventions

DIAGNOSTIC_TEST

Fecal immunochemical test (FIT)

Annual fecal immunochemical test (FIT) for up to five years and follow-up colonoscopy was arranged for those with FIT positive result

DIAGNOSTIC_TEST

Colonoscopy

Subjects in the retrospective cohort were allowed to choose one-off colonoscopy for CRC screening

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • Joseph JY Sung, MD, PhD · Chinese University of Hong Kong

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-10-07
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Hong Kong

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03597204 on ClinicalTrials.gov