Surveillance ColonoscopyNCT04034563
Post-polypectomy Surveillance Interval In High-risk Subjects After Screening Colonoscopy
A study testing 1) Risk of metachronous advanced neoplasia at 3-year, beyond 3 years surveillance colonoscopy in people with Surveillance Colonoscopy, run by Chinese University of Hong Kong at 2 sites in Hong Kong.
Trial summary
With many countries initiating population colorectal cancer (CRC) screening, including Hong Kong, more robust guidance for surveillance interval is required to maximize subject's benefit with optimal use of resources. Surveillance interval after removal of advanced adenoma at screening colonoscopy remains unclear. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surveillance Colonoscopy
- What is being tested?
- 1) Risk of metachronous advanced neoplasia at 3-year, beyond 3 years surveillance colonoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 2 sitesHong Kong
- Study dates
- 1 Feb 2019to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Advanced adenoma at screening colonoscopy
- ≥3 adenomas at screening colonoscopy
- Cecal intubation at screening colonoscopy (preferably documented by images/video of the apendiceal orifice and the ileocecal valve; but not required)
- Complete excision of all polyps at screening colonoscopy findings (after review of endoscopy reports and pathological specimens)
- Eligible for surveillance in out-patient setting
Who cannot join
- Lack of consent
- Incomplete screening colonoscopy
- Incomplete endoscopic excision of polyps at screening colonoscopy
- CRC at screening colonoscopy
- Polyps requiring Endoscopic Submucosal Dissection at screening colonoscopy
- Serrated polyps ≥ 10 mm in diameter at any colorectal location or ≥ 5 mm if located proximal to the splenic flexure on screening colonoscopy
Show all 10Show fewer
- Genetic cancer syndrome (adenomatous or serrated polyposis syndrome; Lynch or Lynch-like syndrome)
- Inflammatory bowel disease
- History of surgical colon resection for any reason
- Severe co-morbidity with reduced life expectancy (NYHA 3-4)
Trial locations and contacts
2 sites in 1 country.
Hong Kong2 sites, 2 recruiting
- Recruiting
Endoscopy Center, Prince of Wales Hospital
Hong Kong
Fanny CHEUNG, 35052231
- Recruiting
S.H. Ho Centre for Digestive Health, Prince of Wales Hospital
Hong Kong
Ming Yeung HO
About this study
Official title: Post-polypectomy Surveillance Interval In High-risk Subjects After Screening Colonoscopy (PPSHR).
With many countries initiating population colorectal cancer (CRC) screening, including Hong Kong, more robust guidance for surveillance interval is required to maximize subject's benefit with optimal use of resources. Surveillance interval after removal of advanced adenoma at screening colonoscopy remains unclear. The current recommendation of 3-year is based on data collected before widespread implementation of population screening programs and quality metrics in colonoscopy. These high-risk subjects are those most likely to benefit from surveillance and represent the majority of the demand in surveillance colonoscopies.
Read the detailed description
The aim of the study is to determine whether the risk of metachronous advanced neoplasia increases if surveillance interval was beyond the current recommendation of 3 years for high-risk subjects with advanced adenoma polyp at screening colonoscopy.
With many countries initiating population colorectal cancer (CRC) screening, including Hong Kong, more robust guidance for surveillance interval is required to maximize subject's benefit with optimal use of resources. Surveillance interval after removal of advanced adenoma at screening colonoscopy remains unclear. The current recommendation of 3-year is based on data collected before widespread implementation of population screening programs and quality metrics in colonoscopy. These high-risk subjects are those most likely to benefit from surveillance and represent the majority of the demand in surveillance colonoscopies.
The investigators hypothesize that the risk of metachronous advanced neoplasia significantly increases if surveillance interval was prolonged beyond 3 years for high-risk subjects. If such is true, our study's findings will provide definitive evidence to existing guidelines and the future Hong Kong population CRC screening programme of setting surveillance interval at 3-year. Conversely, if our study shows that there is no significant increase in risk beyond 3-year surveillance interval, an extended interval of 5-year is justified.
- Conditions
- Surveillance Colonoscopy
- Being tested
- 1) Risk of metachronous advanced neoplasia at 3-year, beyond 3 years surveillance colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1) Risk of metachronous advanced neoplasia at 3-year, beyond 3 years surveillance colonoscopyProcedure or surgery
3-year group: High-risk subjects who have baseline colonoscopy done in 2014, 2015 and 2016 and will be eligible for 3-year surveillance colonoscopy in 2017-2019.
Beyond 3 years group: High-risk subjects who had screening colonoscopy prior 3 years, but not received or scheduled for a surveillance colonoscopy- either due to non-adherence or limited access to surveillance colonoscopy will be eligible for surveillance colonoscopy in 2017-2019.
For the surveillance interval beyond 3 years group, recruitment will be prioritizing to subjects who had the screening colonoscopy at the earliest date. This will in part ensure that subjects in this group will consist those with the longest surveillance interval, leading to an applicable estimation of the risk of metachronous advanced neoplasia beyond 3 years surveillance interval.
| Study group | Role | What they receive |
|---|---|---|
| Risk of advanced neoplasia at 3-year | Other | Risk of metachronous advanced neoplasia in those patients who done surveillance colonoscopy at 3-years Receives: Procedure: 1) Risk of metachronous advanced neoplasia at 3-year, beyond 3 years surveillance colonoscopy |
| Risk of advanced neoplasia beyond 3-year | Other | Risk of metachronous advanced neoplasia in those patients who done surveillance colonoscopy beyond 3-years Receives: Procedure: 1) Risk of metachronous advanced neoplasia at 3-year, beyond 3 years surveillance colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Advanced neoplasia detection rate
Advanced neoplasia detection rate in surveillance colonoscopy among the two groups of patients
Measured: Up to 3 months
Secondary outcomes (1)
CRC detection rate
CRC detection rate in surveillance colonoscopy among the two groups of patients
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study start1 Feb 2019
- Primary completion30 Nov 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surveillance ColonoscopyStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 270 participants (estimated)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04034563
- Sponsor's protocol ID
- PPSHR_PROTOCOL_Ver.1_20170405
- Status last verified
- Jul 2019
- First submitted
- 16 Apr 2019
- Last updated
- 26 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-polypectomy Surveillance Interval In High-risk Subjects After Screening Colonoscopy (PPSHR).
- ClinicalTrials.gov ID
- NCT04034563
- Acronym / sponsor ID
- PPSHR_PROTOCOL_Ver.1_20170405
- Conditions
- Surveillance Colonoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 30 Nov 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 26 Jul 2019 (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.
With many countries initiating population colorectal cancer (CRC) screening, including Hong Kong, more robust guidance for surveillance interval is required to maximize subject's benefit with optimal use of resources. Surveillance interval after removal of advanced adenoma at screening colonoscopy remains unclear. The current recommendation of 3-year is based on data collected before widespread implementation of population screening programs and quality metrics in colonoscopy. These high-risk subjects are those most likely to benefit from surveillance and represent the majority of the demand in surveillance colonoscopies.
Detailed description
The aim of the study is to determine whether the risk of metachronous advanced neoplasia increases if surveillance interval was beyond the current recommendation of 3 years for high-risk subjects with advanced adenoma polyp at screening colonoscopy.
With many countries initiating population colorectal cancer (CRC) screening, including Hong Kong, more robust guidance for surveillance interval is required to maximize subject's benefit with optimal use of resources. Surveillance interval after removal of advanced adenoma at screening colonoscopy remains unclear. The current recommendation of 3-year is based on data collected before widespread implementation of population screening programs and quality metrics in colonoscopy. These high-risk subjects are those most likely to benefit from surveillance and represent the majority of the demand in surveillance colonoscopies.
The investigators hypothesize that the risk of metachronous advanced neoplasia significantly increases if surveillance interval was prolonged beyond 3 years for high-risk subjects. If such is true, our study's findings will provide definitive evidence to existing guidelines and the future Hong Kong population CRC screening programme of setting surveillance interval at 3-year. Conversely, if our study shows that there is no significant increase in risk beyond 3-year surveillance interval, an extended interval of 5-year is justified.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Risk of advanced neoplasia at 3-year | Other | Procedure: 1) Risk of metachronous advanced neoplasia at 3-year, beyond 3 years surveillance colonoscopyRisk of metachronous advanced neoplasia in those patients who done surveillance colonoscopy at 3-years |
| Risk of advanced neoplasia beyond 3-year | Other | Procedure: 1) Risk of metachronous advanced neoplasia at 3-year, beyond 3 years surveillance colonoscopyRisk of metachronous advanced neoplasia in those patients who done surveillance colonoscopy beyond 3-years |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Advanced adenoma at screening colonoscopy
- ≥3 adenomas at screening colonoscopy
- Cecal intubation at screening colonoscopy (preferably documented by images/video of the apendiceal orifice and the ileocecal valve; but not required)
- Complete excision of all polyps at screening colonoscopy findings (after review of endoscopy reports and pathological specimens)
- Eligible for surveillance in out-patient setting
Key exclusion criteria (10 listed)
- Lack of consent
- Incomplete screening colonoscopy
- Incomplete endoscopic excision of polyps at screening colonoscopy
- CRC at screening colonoscopy
- Polyps requiring Endoscopic Submucosal Dissection at screening 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 |
|---|---|---|
| 1) Risk of metachronous advanced neoplasia at 3-year, beyond 3 years surveillance colonoscopy3-year group: High-risk subjects who have baseline colonoscopy done in 2014, 2015 and 2016 and will be eligible for 3-year surveillance colonoscopy in 2017-2019. Beyond 3 years group: High-risk subjects who had screening colonoscopy prior 3 years, but not received or scheduled for a surveillance colonoscopy- either due to non-adherence or limited access to surveillance colonoscopy will be eligible for surveillance colonoscopy in 2017-2019. For the surveillance interval beyond 3 years group, recruitment will be prioritizing to subjects who had the screening colonoscopy at the earliest date. This will in part ensure that subjects in this group will consist those with the longest surveillance interval, leading to an applicable estimation of the risk of metachronous advanced neoplasia beyond 3 years surveillance interval. | Procedure or surgery | Risk of advanced neoplasia at 3-year, Risk of advanced neoplasia beyond 3-year |
Primary outcome
Advanced neoplasia detection rate
Time frame: Up to 3 months
Advanced neoplasia detection rate in surveillance colonoscopy among the two groups of patients
1 secondary outcome
CRC detection rate
Time frame: Up to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2019.
- Individual participant dataSharing planned: No
Related trials for Surveillance Colonoscopy
Recruiting
ULTRA-high-risk Surveillance to Avoid Future Events: the ULTRA-SAFE Trial
Colorectal Neoplasms, Colorectal Cancer Prevention
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1) Risk of metachronous advanced neoplasia at 3-year, beyond 3 years surveillance colonoscopy in people with Surveillance Colonoscopy, run by Chinese University of Hong Kong at 2 sites 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 5 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 26 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ming Yeung Ho (2637 1398, andrewho@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Advanced neoplasia detection rate (time frame: Up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jul 2019; AzTrials last refreshed its copy on 27 Oct 2026.