Active — Not RecruitingNot Applicable

Effectiveness of Fecal Immunnochemical Test and Colonoscopy Screening in Hong Kong

Hong Kong15,000 participantsStarted 2015-10-07

Plain-language 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.

Who can participate

Age range

40 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Subjects aged 40-75 who were asymptomatic of CRC from CUHK JC Bowel Cancer Education Centre
. Informed consent available
. Identified as having risk factors for CRC (defined as having a Asia Pacific Colorectal Screening (APCS) score 4-7; the presence of diabetes; body mass index ≥25 kg/m2; or the presence of family history of CRC)

Exclusion criteria

. Subject with any lower gastrointestinal (GI) symptoms (including lower GI bleeding, change in bowel habit, anemia and weight loss)
. Prior history of colonic diseases that might increase the risk of colorectal cancer (including colorectal neoplasm, inflammatory bowel disease)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of subjects diagnosed colonic adenoma, advanced adenoma or cancer

Timeframe: Up to three years

Long-term CRC incidence and mortality and all-cause mortality

Timeframe: At least 10 years

Trial details

NCT IDNCT03597204

SponsorChinese University of Hong Kong

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-31

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