Colorectal CancerNCT03597204
Effectiveness of Fecal Immunnochemical Test and Colonoscopy Screening in Hong Kong
A study testing Fecal immunochemical test (FIT) and Colonoscopy in people with Colorectal Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Fecal immunochemical test (FIT) and Colonoscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15,000 participants
- Where
- 1 siteHong Kong
- Study dates
- 7 Oct 2015to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Retrospective cohort
- 1. Subjects received CRC screening in CUHK JC Bowel Cancer Education Centre from 2008 up to 30 Sept 2015
- Prospective cohort
- 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)
Who cannot join
- 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)
- Examination of the colon (e.g. colonoscopy, barium enema or CT/MR of the colon) within the past 5 years
- History of colorectal surgery in the past
- Any contraindication for colonoscopy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Colorectal Cancer (CRC) Screening in Hong Kong: an Analysis on Acceptability, Compliance, Diagnostic Accuracy and Clinical Outcomes
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:
- . Evaluate the knowledge, attitude, perception, practice, perceived obstacles and changes in choice of CRC screening among the screening participants;
- . Assess the levels of compliance across time among those who joined the screening programme, according to different subject characteristics;
- . Explore the diagnostic accuracy of faecal immunochemical tests among subjects with different characteristics;
- . 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;
- . Evaluate the association between bowel preparation, colonoscopy withdrawal time and adenoma detection rate among those who received colonoscopy;
- . Validation of the existing risk scoring systems for colorectal neoplasia from the literature, based on findings from subjects who received colonoscopy.
- . Explore potential associations among colorectal neoplasia detected in different colon sites.
Read the detailed description
BACKGROUND
Colorectal neoplasm in Asia is not less common compared to that of the Western population and screening for colorectal cancer (CRC) should be implemented. In the Asia Pacific Consensus for Colorectal Cancer, Fecal Occult Blood Test (FOBT) was recommended as the preferred test in resource limited areas in Asia. Yet, the preference of Asian in the options for CRC screening might be different. In a recent study from Hong Kong, most subjects preferred to use colonoscopy instead of stool tests as the screening tool.
A study from Asia showed that fecal immunochemical test (FIT) might be preferred because it obviates the need for dietary control. Educating the public about different options available is an important method to change the health seeking behavior of subjects. The CUHK JC Bowel Cancer Education Centre was established in 2008 with full funding from the Hong Kong Jockey Club Charities Trust. About 10,000 subjects received CRC screening by either FIT or colonoscopy till 31 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, a total of about 2,500 asymptomatic subjects have received CRC screening in this new project and the Centre will continue to recruit 2,500 subjects more till 31 December 2017.
To inform future screening policy for implementation of population-based screening, it is important to explore the different aspects of this community-based CRC screening programme which include various indicators of programmatic performance.
STUDY AIMS
- Evaluate the knowledge, attitude, perception, practice, perceived obstacles and changes in choice of CRC screening among the screening participants;
- Assess the levels of compliance across time among those who joined the screening programme, according to different subject characteristics;
- Explore the diagnostic accuracy of faecal immunochemical tests among subjects with different characteristics;
- 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;
- Evaluate the association between bowel preparation, colonoscopy withdrawal time and adenoma detection rate among those who received colonoscopy;
- Validation of the existing risk scoring systems for colorectal neoplasia from the literature, based on findings from subjects who received colonoscopy.
- Explore potential associations among colorectal neoplasia detected in different colon sites.
- Evaluate the long-term protective effect of FIT and colonoscopy on CRC incidence and mortality and all-cause mortality.
METHODOLOGY
Retrospective cohort Demographic data, health behavior information and clinical outcomes of subjects who received CRC screening in CUHK Bowel Cancer Education Centre from December 2008 to Sept 2015 will be retrospectively reviewed without consent and analyzed.
Prospective cohort
- Study subjects will be invited to join the study via routine health talk of a CRC screening program organized by CUHK JC Bowel Cancer Education Centre
- Each eligible subject completed a self-administered survey, which consists of sociodemographic information, family history of CRC for a first-degree relative, past medical history, and use of chronic medications. The completeness of questionnaires is checked afterwards. Trained volunteers assist survey completion for the relatively illiterate participants. The investigators used a quantitative FIT (OC Sensor). Participants received information on procedures for collecting the FIT samples at home, according to the manufacturer's instructions. They are requested to return their collection tubes containing faecal specimens to the centre 6 days within the stool collection. For those with negative FIT, they will be reminded to continue the FIT screening on a yearly basis till 2018. For those subjects with FIT positive findings, according to local practice, they will be offered a routine colonoscopy as they will be treated as symptomatic. Subjects who undergo colonoscopy may receive a phone-call follow up every year for the period of the study to monitor the clinical outcome of the subject. Subjects develop symptoms suggestive of colorectal neoplasm will be worked up by the original team of investigators.
Long-term Follow-up Follow-up with respect to long-term CRC incidence, CRC-related mortality and all-cause mortality will be conducted by matching participants' unique identifier to the Clinical Data Analysis and Reporting System (CDARS), Hospital Authority. A diagnosis of CRC will be defined as cancer in the colon or rectum, according to ICD-9 coding of 153.0-154.1 or 154.8. Follow-up time will be measured from the date of enrolment to the date of diagnosis of CRC, date of death (CRC-related or other cause), or the end of follow up (30 Nov 2023), whichever came first. The Kaplan-Meier (KM) estimator will be used to calculate the cumulative risks of CRC incidence, CRC-related mortality and all-cause mortality
- Conditions
- Colorectal Cancer
- Being tested
- Fecal immunochemical test (FIT), Colonoscopy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal immunochemical test (FIT)Diagnostic test
Annual fecal immunochemical test (FIT) for up to five years and follow-up colonoscopy was arranged for those with FIT positive result
ColonoscopyDiagnostic test
Subjects in the retrospective cohort were allowed to choose one-off colonoscopy for CRC screening
| Study group | Role | What they receive |
|---|---|---|
| Fecal immunochemical test (FIT) | Active comparator | Annual fecal immunochemical test (FIT) for up to five years and follow-up colonoscopy was arranged for those with FIT positive result Receives: Diagnostic Test: Fecal immunochemical test (FIT) |
| Colonoscopy | Active comparator | Subjects in the retrospective cohort were allowed to choose one-off colonoscopy for CRC screening Receives: Diagnostic Test: Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects diagnosed colonic adenoma, advanced adenoma or cancer
The diagnostic accuracy of faecal immunochemical test in the selected high risk individuals. The number of subjects diagnosed colonic adenoma, advanced adenoma or cancer will be divided by the total number of selected high risk subjects received fecal immunochemical test
Measured: Up to three years
Long-term CRC incidence and mortality and all-cause mortality
Measured: At least 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2018
- Study start7 Oct 2015
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph JY SUNG, Chinese University of Hong Kong
- Investigators
- Joseph JY Sung, MD, PhD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03597204
- Sponsor's protocol ID
- CEHR
- Status last verified
- Jul 2025
- First submitted
- 18 Jun 2018
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhu Z, Lam TYT, Tang RSY, Wong SH, Lui RNS, Ng SSM, Wong SYS, Sung JJY. Triglyceride-glucose index (TyG index) is associated with a higher risk of colorectal adenoma and multiple adenomas in asymptomatic subjects. PLoS One. 2024 Nov 7;19(11):e0310526. doi: 10.1371/journal.pone.0310526. eCollection 2024.
PubMed 39509387
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colorectal Cancer (CRC) Screening in Hong Kong: an Analysis on Acceptability, Compliance, Diagnostic Accuracy and Clinical Outcomes
- ClinicalTrials.gov ID
- NCT03597204
- Acronym / sponsor ID
- CEHR
- Conditions
- Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15,000 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 7 Oct 2015 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 24 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- . Evaluate the knowledge, attitude, perception, practice, perceived obstacles and changes in choice of CRC screening among the screening participants;
- . Assess the levels of compliance across time among those who joined the screening programme, according to different subject characteristics;
- . Explore the diagnostic accuracy of faecal immunochemical tests among subjects with different characteristics;
- . 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;
- . Evaluate the association between bowel preparation, colonoscopy withdrawal time and adenoma detection rate among those who received colonoscopy;
- . Validation of the existing risk scoring systems for colorectal neoplasia from the literature, based on findings from subjects who received colonoscopy.
- . Explore potential associations among colorectal neoplasia detected in different colon sites.
Detailed description
BACKGROUND
Colorectal neoplasm in Asia is not less common compared to that of the Western population and screening for colorectal cancer (CRC) should be implemented. In the Asia Pacific Consensus for Colorectal Cancer, Fecal Occult Blood Test (FOBT) was recommended as the preferred test in resource limited areas in Asia. Yet, the preference of Asian in the options for CRC screening might be different. In a recent study from Hong Kong, most subjects preferred to use colonoscopy instead of stool tests as the screening tool.
A study from Asia showed that fecal immunochemical test (FIT) might be preferred because it obviates the need for dietary control. Educating the public about different options available is an important method to change the health seeking behavior of subjects. The CUHK JC Bowel Cancer Education Centre was established in 2008 with full funding from the Hong Kong Jockey Club Charities Trust. About 10,000 subjects received CRC screening by either FIT or colonoscopy till 31 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, a total of about 2,500 asymptomatic subjects have received CRC screening in this new project and the Centre will continue to recruit 2,500 subjects more till 31 December 2017.
To inform future screening policy for implementation of population-based screening, it is important to explore the different aspects of this community-based CRC screening programme which include various indicators of programmatic performance.
STUDY AIMS
- Evaluate the knowledge, attitude, perception, practice, perceived obstacles and changes in choice of CRC screening among the screening participants;
- Assess the levels of compliance across time among those who joined the screening programme, according to different subject characteristics;
- Explore the diagnostic accuracy of faecal immunochemical tests among subjects with different characteristics;
- 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;
- Evaluate the association between bowel preparation, colonoscopy withdrawal time and adenoma detection rate among those who received colonoscopy;
- Validation of the existing risk scoring systems for colorectal neoplasia from the literature, based on findings from subjects who received colonoscopy.
- Explore potential associations among colorectal neoplasia detected in different colon sites.
- Evaluate the long-term protective effect of FIT and colonoscopy on CRC incidence and mortality and all-cause mortality.
METHODOLOGY
Retrospective cohort Demographic data, health behavior information and clinical outcomes of subjects who received CRC screening in CUHK Bowel Cancer Education Centre from December 2008 to Sept 2015 will be retrospectively reviewed without consent and analyzed.
Prospective cohort
- Study subjects will be invited to join the study via routine health talk of a CRC screening program organized by CUHK JC Bowel Cancer Education Centre
- Each eligible subject completed a self-administered survey, which consists of sociodemographic information, family history of CRC for a first-degree relative, past medical history, and use of chronic medications. The completeness of questionnaires is checked afterwards. Trained volunteers assist survey completion for the relatively illiterate participants. The investigators used a quantitative FIT (OC Sensor). Participants received information on procedures for collecting the FIT samples at home, according to the manufacturer's instructions. They are requested to return their collection tubes containing faecal specimens to the centre 6 days within the stool collection. For those with negative FIT, they will be reminded to continue the FIT screening on a yearly basis till 2018. For those subjects with FIT positive findings, according to local practice, they will be offered a routine colonoscopy as they will be treated as symptomatic. Subjects who undergo colonoscopy may receive a phone-call follow up every year for the period of the study to monitor the clinical outcome of the subject. Subjects develop symptoms suggestive of colorectal neoplasm will be worked up by the original team of investigators.
Long-term Follow-up Follow-up with respect to long-term CRC incidence, CRC-related mortality and all-cause mortality will be conducted by matching participants' unique identifier to the Clinical Data Analysis and Reporting System (CDARS), Hospital Authority. A diagnosis of CRC will be defined as cancer in the colon or rectum, according to ICD-9 coding of 153.0-154.1 or 154.8. Follow-up time will be measured from the date of enrolment to the date of diagnosis of CRC, date of death (CRC-related or other cause), or the end of follow up (30 Nov 2023), whichever came first. The Kaplan-Meier (KM) estimator will be used to calculate the cumulative risks of CRC incidence, CRC-related mortality and all-cause mortality
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fecal immunochemical test (FIT) | Active comparator | 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 |
| Colonoscopy | Active comparator | Diagnostic Test: ColonoscopySubjects in the retrospective cohort were allowed to choose one-off colonoscopy for CRC screening |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Retrospective cohort
- 1. Subjects received CRC screening in CUHK JC Bowel Cancer Education Centre from 2008 up to 30 Sept 2015
- Prospective cohort
- Subjects aged 40-75 who were asymptomatic of CRC from CUHK JC Bowel Cancer Education Centre
- Informed consent available
Key exclusion criteria (5 listed)
- 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)
- Examination of the colon (e.g. colonoscopy, barium enema or CT/MR of the colon) within the past 5 years
- History of colorectal surgery in the past
- Any contraindication for colonoscopy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Fecal immunochemical test (FIT) |
| ColonoscopySubjects in the retrospective cohort were allowed to choose one-off colonoscopy for CRC screening | Diagnostic test | Colonoscopy |
Primary outcome
Number of subjects diagnosed colonic adenoma, advanced adenoma or cancer
Time frame: Up to three years
The diagnostic accuracy of faecal immunochemical test in the selected high risk individuals. The number of subjects diagnosed colonic adenoma, advanced adenoma or cancer will be divided by the total number of selected high risk subjects received fecal immunochemical test
Long-term CRC incidence and mortality and all-cause mortality
Time frame: At least 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Derived from this study: PubMed 39509387Zhu Z, Lam TYT, Tang RSY, Wong SH, Lui RNS, Ng SSM, Wong SYS, Sung JJY. Triglyceride-glucose index (TyG index) is associated with a higher risk of colorectal adenoma and multiple adenomas in asymptomatic subjects. PLoS One. 2024 Nov 7;19(11):e0310526. doi: 10.1371/journal.pone.0310526. eCollection 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph JY Sung, MD, PhD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fecal immunochemical test (FIT) and Colonoscopy in people with Colorectal Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects diagnosed colonic adenoma, advanced adenoma or cancer (time frame: Up to three years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03597204, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.