NCT03597204

Effectiveness of Fecal Immunnochemical Test and Colonoscopy Screening in Hong Kong

Active, enrolled NA Last updated 23 July 2025

What this trial tests

NA trial testing Fecal immunochemical test (FIT) in Colorectal Cancer in 15,000 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

7 October 2015

Primary endpoint
31 December 2025

31 December 2025

Quick facts

Lead sponsor	Chinese University of Hong Kong
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	15,000
Start date	7 October 2015
Primary completion	31 December 2025
Estimated completion	31 December 2025
Sites	1 location across Hong Kong

Drugs / interventions tested

• Fecal immunochemical test (FIT)
• Colonoscopy

Conditions studied

• Colorectal Cancer — all drugs for Colorectal Cancer →

Sponsor

Chinese University of Hong Kong

Who can join

Adults 40 to 75, any sex, with Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Triglyceride-glucose index (TyG index) is associated with a higher risk of colorectal adenoma and multiple adenomas in asymptomatic subjects.
   Zhu Z, Lam TYT, Tang RSY, Wong SH, et al · · 2024 · cited 5× · PMID 39509387 · DOI 10.1371/journal.pone.0310526