To Evaluate the Sensitivity and Specificity of a Test Kit in Hong KongNCT04030637
The Diagnostic Accuracy of Using Faecal-DNA Test (COLOSAFE) for Colorectal Cancer Screening
An observational study of To Evaluate the Sensitivity and Specificity of a Test Kit in Hong Kong, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
To evaluate the sensitivity and specificity of the test kit "COLOSAFE' in Hong Kong Read more about this study
- Who is it for?
- Ages 45 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- To Evaluate the Sensitivity and Specificity of a Test Kit in Hong Kong
- How many people
- 400 participants
- Where
- 1 siteHong Kong
- Study dates
- 11 Feb 2019to 28 Feb 2020
- Phase
- Observational
- 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 45 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A total of 400 individuals aged 45-79 years will be consecutively recruited for this study. Among them, we aim to recruit 150 subjects with known diagnosis of CRC; 150 subjects with normal colonoscopy findings; and 100 subjects whose colonoscopies showed other pathologies (e.g. inflammatory polyps, adenomas, diverticular diseases). To enhance comparability of the cases and the controls, we aim to recruit these subjects in the same hospital (medical or surgical clinics of the Prince of Wales Hospital). Stool samples will be collected within 8 days to 3 months after the individuals received colonoscopy, but before any treatments, including surgery, chemotherapy, and radiotherapy. We aim to match cases and controls by their age and gender.
Who may be able to join
- CRC patients, individuals with normal colonoscopy findings, or patients with other colorectal pathologies;
- Chinese subjects aged 45 to 79 years living in Hong Kong for most of the time in the past 5 years;
- Having received colonoscopy within 8 days to 3 months before enrolment in the study);
- Absence of medical conditions that render the subject unable to comprehend the study;
- Willing to provide informed consent;
- Willing to provide faecal sample for laboratory investigation in the present study.
Who cannot join
- History of major chronic illnesses which are serious (including those with respiratory, cardiac, renal, liver or immune function impairment or requiring long-term immunosuppressive therapy);
- Previous history of inflammatory bowel diseases or digestive cancers other than CRC;
- History of colorectal resection for any reason other than sigmoid diverticula;
- Had a surgery or an invasive procedure within the past 3 months;
- Received chemotherapy or radiotherapy with the past 3 months;
- Had participated in any interventional clinical study within the previous 30 days.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital
Hong Kong
Ming Yeung HO, 26371398, andrewho@cuhk.edu.hk
About this study
To evaluate the sensitivity and specificity of the test kit "COLOSAFE' in Hong Kong
Read the detailed description
Colorectal cancer (CRC) remains to be a leading cause of cancer mortality [1]. It induces a substantial financial burden in terms of healthcare utilization and quality-adjusted life years (QALY) lost [2]. Fecal Occult Blood Tests (FOBT) and colonoscopy were proven effective in reducing CRC mortality by 33% and 68%, respectively [3-5]. Both tests have been proposed as primary screening modalities for asymptomatic subjects by international guidelines and Asia Pacific consensus statements [6-8]. However, colonoscopy has a low compliance rate at approximately 20% in Chinese populations, and has been perceived by screening participants as invasive, expensive and inconvenient due to the need for bowel preparation [9, 10]. In addition, the accuracy of FOBT is limited and its adherence declined sharply over time [11, 12]. Hence, the recent decade witnessed a rapid development of non-invasive biomarkers to detect CRC.
Faecal-DNA test is a novel screening test for CRC, using molecular techniques to identify CRC-relevant biomarkers in stool. One of its toolkits, branded 'ColoGuard' (sDNA, Exact Sciences), was first approved by the FDA in 2014 for its application in clinical practice [13]. It consists of quantitative molecular assays for KRAS mutations, aberrant NDRG4 and BMP3 methylation, and β-actin, and a hemoglobin immunoassay [13], which has been widely promoted in US. In 2016, it was endorsed by the United States Preventive Service Task Force (USPSTF) as one of the recommended screening tests [14].
Recently, a test kit named 'COLOSAFE' (or namedChang An Xin) has been developed as a faecal-DNA product targeted to improve diagnostic accuracy of CRC screening [15]. It is a stool test of methylated SDC2 for detection of CRC. This stool test of methylated SDC2 detected 81.1% of CRC and 58.2% of adenomas at a specificity of 93.3%. SDC2 is also named fibroglycan, encoding a type I trans-membrane heparansulfate proteoglycan. In certain cancers, hypermethylation of SDC2 had been reported. Recent studies showed that methylated SDC2 was detected at high frequency in blood from CRC patients [16, 17]. As tumor cells are exfoliated into the gut lumen earlier than vascular invasion when CRC develops [18], faecal sample could represent a more suitable specimen than plasma for detection of early cancer.
A recent study involving 1,200 subjects from 2015 to 2017 by the Sixth Affiliated Hospital of Sun Yat-sen University, Nanfang Hospital of Southern Medical University and Shandong Cancer Hospital showed that the 'COLOSAFE' test kit attained a sensitivity of 85% while maintaining a specificity of 98% (unpublished data). Because of its novelty, the 'COLOSAFEtest kit was recognized as a 'creative medical apparatus' by the National CFDA in March 2017. In June 2017, the project 'Screening and intervention research of Chinese CRC' (2017YFC 1308800) was launched with national key project for non-communicable disease control. Nevertheless, there are limitations with the design of the original study [15]. For instance, it involved a small, single-centre that recruited a homogeneous sample of individuals only. An important knowledge gap exists and additional clinical trials are required to further validate its diagnostic accuracy in other populations.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CRC cases | samples will be collected from subjects with known diagnosis of colorectal cancer | |
| Healthy cases | samples will be collected from healthy subjects with normal colonoscopy findings | |
| Cases with pathologies | samples will be collected from subjects whose colonoscopies showed other pathologies (e.g. inflammatory polyps, adenomas, diverticular diseases) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of COLOSAFE
Sensitivity, specificity, positive predictive value and negative predictive value in detection of CRC by COLOSAFE
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2019
- Study start11 Feb 2019
- Primary completion1 Jan 2020 (estimated)
- Study completion28 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Evaluate the Sensitivity and Specificity of a Test Kit in Hong KongStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 400 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
- NCT04030637
- Sponsor's protocol ID
- Protocol_v21_20190110
- Status last verified
- Jul 2019
- First submitted
- 16 Apr 2019
- Last updated
- 24 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnostic Accuracy of Using Faecal-DNA Test (COLOSAFE) for Colorectal Cancer Screening
- ClinicalTrials.gov ID
- NCT04030637
- Acronym / sponsor ID
- Protocol_v21_20190110
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 11 Feb 2019 (actual)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 28 Feb 2020 (estimated)
- First posted
- 24 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.
To evaluate the sensitivity and specificity of the test kit "COLOSAFE' in Hong Kong
Detailed description
Colorectal cancer (CRC) remains to be a leading cause of cancer mortality [1]. It induces a substantial financial burden in terms of healthcare utilization and quality-adjusted life years (QALY) lost [2]. Fecal Occult Blood Tests (FOBT) and colonoscopy were proven effective in reducing CRC mortality by 33% and 68%, respectively [3-5]. Both tests have been proposed as primary screening modalities for asymptomatic subjects by international guidelines and Asia Pacific consensus statements [6-8]. However, colonoscopy has a low compliance rate at approximately 20% in Chinese populations, and has been perceived by screening participants as invasive, expensive and inconvenient due to the need for bowel preparation [9, 10]. In addition, the accuracy of FOBT is limited and its adherence declined sharply over time [11, 12]. Hence, the recent decade witnessed a rapid development of non-invasive biomarkers to detect CRC.
Faecal-DNA test is a novel screening test for CRC, using molecular techniques to identify CRC-relevant biomarkers in stool. One of its toolkits, branded 'ColoGuard' (sDNA, Exact Sciences), was first approved by the FDA in 2014 for its application in clinical practice [13]. It consists of quantitative molecular assays for KRAS mutations, aberrant NDRG4 and BMP3 methylation, and β-actin, and a hemoglobin immunoassay [13], which has been widely promoted in US. In 2016, it was endorsed by the United States Preventive Service Task Force (USPSTF) as one of the recommended screening tests [14].
Recently, a test kit named 'COLOSAFE' (or namedChang An Xin) has been developed as a faecal-DNA product targeted to improve diagnostic accuracy of CRC screening [15]. It is a stool test of methylated SDC2 for detection of CRC. This stool test of methylated SDC2 detected 81.1% of CRC and 58.2% of adenomas at a specificity of 93.3%. SDC2 is also named fibroglycan, encoding a type I trans-membrane heparansulfate proteoglycan. In certain cancers, hypermethylation of SDC2 had been reported. Recent studies showed that methylated SDC2 was detected at high frequency in blood from CRC patients [16, 17]. As tumor cells are exfoliated into the gut lumen earlier than vascular invasion when CRC develops [18], faecal sample could represent a more suitable specimen than plasma for detection of early cancer.
A recent study involving 1,200 subjects from 2015 to 2017 by the Sixth Affiliated Hospital of Sun Yat-sen University, Nanfang Hospital of Southern Medical University and Shandong Cancer Hospital showed that the 'COLOSAFE' test kit attained a sensitivity of 85% while maintaining a specificity of 98% (unpublished data). Because of its novelty, the 'COLOSAFEtest kit was recognized as a 'creative medical apparatus' by the National CFDA in March 2017. In June 2017, the project 'Screening and intervention research of Chinese CRC' (2017YFC 1308800) was launched with national key project for non-communicable disease control. Nevertheless, there are limitations with the design of the original study [15]. For instance, it involved a small, single-centre that recruited a homogeneous sample of individuals only. An important knowledge gap exists and additional clinical trials are required to further validate its diagnostic accuracy in other populations.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CRC cases | – | –samples will be collected from subjects with known diagnosis of colorectal cancer |
| Healthy cases | – | –samples will be collected from healthy subjects with normal colonoscopy findings |
| Cases with pathologies | – | –samples will be collected from subjects whose colonoscopies showed other pathologies (e.g. inflammatory polyps, adenomas, diverticular diseases) |
Who may qualify
- Ages
- 45 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 400 individuals aged 45-79 years will be consecutively recruited for this study. Among them, we aim to recruit 150 subjects with known diagnosis of CRC; 150 subjects with normal colonoscopy findings; and 100 subjects whose colonoscopies showed other pathologies (e.g. inflammatory polyps, adenomas, diverticular diseases). To enhance comparability of the cases and the controls, we aim to recruit these subjects in the same hospital (medical or surgical clinics of the Prince of Wales Hospital). Stool samples will be collected within 8 days to 3 months after the individuals received colonoscopy, but before any treatments, including surgery, chemotherapy, and radiotherapy. We aim to match cases and controls by their age and gender.
Key inclusion criteria (6 listed)
- CRC patients, individuals with normal colonoscopy findings, or patients with other colorectal pathologies;
- Chinese subjects aged 45 to 79 years living in Hong Kong for most of the time in the past 5 years;
- Having received colonoscopy within 8 days to 3 months before enrolment in the study);
- Absence of medical conditions that render the subject unable to comprehend the study;
- Willing to provide informed consent;
Key exclusion criteria (6 listed)
- History of major chronic illnesses which are serious (including those with respiratory, cardiac, renal, liver or immune function impairment or requiring long-term immunosuppressive therapy);
- Previous history of inflammatory bowel diseases or digestive cancers other than CRC;
- History of colorectal resection for any reason other than sigmoid diverticula;
- Had a surgery or an invasive procedure within the past 3 months;
- Received chemotherapy or radiotherapy with the past 3 months;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accuracy of COLOSAFE
Time frame: 1 year
Sensitivity, specificity, positive predictive value and negative predictive value in detection of CRC by COLOSAFE
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of To Evaluate the Sensitivity and Specificity of a Test Kit in Hong Kong, 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 6 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 24 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 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?
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?
Accuracy of COLOSAFE (time frame: 1 year). 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 24 Jul 2019.