Colorectal CancerNCT04194879
Effectiveness of Multi-target FIT-DNA Analysis as a Colorectal Cancer Screening Test
An observational study of Colorectal Cancer and Adenoma Colon, run by The University of Hong Kong.
Trial summary
Colorectal cancer is one of the most common cancer in Hong Kong. In 2018, CRC accounted for 17.4%, 5,780 cases, of the total new cancers. CRC claimed 2,279 lives (15.8%) making it the second most deadly killer in the population. Read more about this study
- Who is it for?
- Ages 40 to 74 years
- Conditions the study is for
- Colorectal Cancer, Adenoma Colon
- What is being tested?
- multi-target FIT-DNA analysis
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2020to 1 Jul 2021
- 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 40 to 74 years
- All sexes
- Adult, Older adult
Study population: 300 subjects (assume 20% drop out rate)
Who may be able to join
- Subject is at average risk for development of CRC.
- Subject is male or female (all Asian), 40-74 years of age.
- Subject is able to comprehend, sign and date the written informed consent form to participate in this study, undergo study procedures described in the informed consent form and authorizes release of relevant protected health information through signing an informed consent form.
Who cannot join
- Subject undergone colonoscopy and removal of lesions within 5 years.
- Subject with Familial Adenomatous Polyposis (FAP) and Inflammatory Bowel Disease (IBD) including chronic ulcerative colitis (CUC) and Crohn's disease.
- Subject with overt rectal bleeding, e.g., hematochezia or melena, within the previous 30 days.
- Any condition which, in the opinion of the investigator should preclude participation in the study.
Trial locations and contacts
No sites are listed yet.
Tak Ka Man contact
About this study
Colorectal cancer is one of the most common cancer in Hong Kong. In 2018, CRC accounted for 17.4%, 5,780 cases, of the total new cancers. CRC claimed 2,279 lives (15.8%) making it the second most deadly killer in the population.
Since 2010, the Cancer Expert Working Group (CEWG) has recommended that asymptomatic average-risk individuals aged 50 to 75 years should consider one of the screening methods: fecal occult blood test (FOBT) every one to two years; OR flexible sigmoidoscopy every 5 years; OR colonoscopy every 10 years. However, it poses great challenges for large scale CRC screening using colonoscopy, such as bowel preparation difficulties, complications of procedure and poor compliance.
ColoClear® is intended for use as an adjunctive screening test for the detection of colorectal neoplasia associated DNA markers and for the presence of occult hemoglobin in human stool. It has the potential of increasing the sensitivity of detecting CRC as compared to FOBT or faecal immunochemical test (FIT), which detects the presence of hemoglobin in stool alone. A positive result may indicate the presence of colorectal cancer or pre-malignant colorectal neoplasia. ColoClear® is not intended as a replacement for diagnostic colonoscopy. A positive result in ColoClear®, as with any screening test, should be followed by colonoscopy. ColoClear® is intended for colorectal cancer screening in average risk individuals: adults of either sex, 40 years or older, who are at high risk for colorectal cancer.
Read the detailed description
The objective of this study is to evaluate the clinical performance of ColoClear test in early screening of colorectal cancer in Hong Kong. Other outcomes to analyze include, but are not limited to the point estimate of the sensitivity of ColoClear for the detection of advanced adenoma (AA) in Hong Kong.
- Conditions
- Colorectal Cancer, Adenoma Colon
- Being tested
- multi-target FIT-DNA analysis
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multi-target FIT-DNA analysisDiagnostic test
Also called Coloclear
ColoClear® is intended for use as an adjunctive screening test for the detection of colorectal neoplasia associated DNA markers and for the presence of occult hemoglobin in human stool. It has the potential of increasing the sensitivity of detecting CRC as compared to FOBT or faecal immunochemical test (FIT), which detects the presence of hemoglobin in stool alone. A positive result may indicate the presence of colorectal cancer or pre-malignant colorectal neoplasia. ColoClear® is not intended as a replacement for diagnostic colonoscopy. A positive result in ColoClear®, as with any screening test, should be followed by colonoscopy. ColoClear® is intended for colorectal cancer screening in average risk individuals: adults of either sex, 40 years or older, who are at high risk for colorectal cancer.
| Study group | Role | What they receive |
|---|---|---|
| Cancer | Case subjects (at least 50) will be men and women age 40-74 who are recently diagnosed, through colonoscopy, with different stages of colorectal cancer and have not yet had surgical intervention. Receives: Diagnostic Test: multi-target FIT-DNA analysis | |
| Negative | Approximately 250 prospectively enrolled subjects will be men and women age 40-74 who are at average risk of developing colorectal cancer and eligible for colonoscopy. About 150 Control subjects will be enrolled prospectively, who have no colorectal neoplasia detected on colonoscopy, including cancer, advanced adenoma, sessile serrated lesions and small, non-advanced adenoma. Receives: Diagnostic Test: multi-target FIT-DNA analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity & specificity of colorectal cancer detection
The primary endpoint is the point estimate of sensitivity and specificity of ColoClear for screening of CRC.
Measured: within 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start1 Jan 2020 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion1 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by The 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Dominic C.C. Foo, The University of Hong Kong
- Investigators
- Dominic CC Foo, MBBS, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04194879
- Sponsor's protocol ID
- UW 19-784
- Status last verified
- Dec 2019
- First submitted
- 8 Dec 2019
- Last updated
- 11 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data could be stored in a public repository for other researchers after completion
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Multi-target FIT-DNA Analysis as a Colorectal Cancer Screening Test
- ClinicalTrials.gov ID
- NCT04194879
- Acronym / sponsor ID
- UW 19-784
- Conditions
- Colorectal Cancer, Adenoma Colon
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 11 Dec 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.
Colorectal cancer is one of the most common cancer in Hong Kong. In 2018, CRC accounted for 17.4%, 5,780 cases, of the total new cancers. CRC claimed 2,279 lives (15.8%) making it the second most deadly killer in the population.
Since 2010, the Cancer Expert Working Group (CEWG) has recommended that asymptomatic average-risk individuals aged 50 to 75 years should consider one of the screening methods: fecal occult blood test (FOBT) every one to two years; OR flexible sigmoidoscopy every 5 years; OR colonoscopy every 10 years. However, it poses great challenges for large scale CRC screening using colonoscopy, such as bowel preparation difficulties, complications of procedure and poor compliance.
ColoClear® is intended for use as an adjunctive screening test for the detection of colorectal neoplasia associated DNA markers and for the presence of occult hemoglobin in human stool. It has the potential of increasing the sensitivity of detecting CRC as compared to FOBT or faecal immunochemical test (FIT), which detects the presence of hemoglobin in stool alone. A positive result may indicate the presence of colorectal cancer or pre-malignant colorectal neoplasia. ColoClear® is not intended as a replacement for diagnostic colonoscopy. A positive result in ColoClear®, as with any screening test, should be followed by colonoscopy. ColoClear® is intended for colorectal cancer screening in average risk individuals: adults of either sex, 40 years or older, who are at high risk for colorectal cancer.
Detailed description
The objective of this study is to evaluate the clinical performance of ColoClear test in early screening of colorectal cancer in Hong Kong. Other outcomes to analyze include, but are not limited to the point estimate of the sensitivity of ColoClear for the detection of advanced adenoma (AA) in Hong Kong.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cancer | – | Diagnostic Test: multi-target FIT-DNA analysisCase subjects (at least 50) will be men and women age 40-74 who are recently diagnosed, through colonoscopy, with different stages of colorectal cancer and have not yet had surgical intervention. |
| Negative | – | Diagnostic Test: multi-target FIT-DNA analysisApproximately 250 prospectively enrolled subjects will be men and women age 40-74 who are at average risk of developing colorectal cancer and eligible for colonoscopy. About 150 Control subjects will be enrolled prospectively, who have no colorectal neoplasia detected on colonoscopy, including cancer, advanced adenoma, sessile serrated lesions and small, non-advanced adenoma. |
Who may qualify
- Ages
- 40 to 74 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 300 subjects (assume 20% drop out rate)
Key inclusion criteria (3 listed)
- Subject is at average risk for development of CRC.
- Subject is male or female (all Asian), 40-74 years of age.
- Subject is able to comprehend, sign and date the written informed consent form to participate in this study, undergo study procedures described in the informed consent form and authorizes release of relevant protected health information through signing an informed consent form.
Key exclusion criteria (4 listed)
- Subject undergone colonoscopy and removal of lesions within 5 years.
- Subject with Familial Adenomatous Polyposis (FAP) and Inflammatory Bowel Disease (IBD) including chronic ulcerative colitis (CUC) and Crohn's disease.
- Subject with overt rectal bleeding, e.g., hematochezia or melena, within the previous 30 days.
- Any condition which, in the opinion of the investigator should preclude participation in the study.
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 |
|---|---|---|
| multi-target FIT-DNA analysisAlso: ColoclearColoClear® is intended for use as an adjunctive screening test for the detection of colorectal neoplasia associated DNA markers and for the presence of occult hemoglobin in human stool. It has the potential of increasing the sensitivity of detecting CRC as compared to FOBT or faecal immunochemical test (FIT), which detects the presence of hemoglobin in stool alone. A positive result may indicate the presence of colorectal cancer or pre-malignant colorectal neoplasia. ColoClear® is not intended as a replacement for diagnostic colonoscopy. A positive result in ColoClear®, as with any screening test, should be followed by colonoscopy. ColoClear® is intended for colorectal cancer screening in average risk individuals: adults of either sex, 40 years or older, who are at high risk for colorectal cancer. | Diagnostic test | Cancer, Negative |
Primary outcome
Sensitivity & specificity of colorectal cancer detection
Time frame: within 3 months
The primary endpoint is the point estimate of sensitivity and specificity of ColoClear for screening of CRC.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2019.
- Individual participant dataSharing planned: Undecided. The data could be stored in a public repository for other researchers after completion
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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.
Tak Ka Man contact
Dominic CC Foo, MBBS principal investigator
The University of Hong Kong
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Adenoma Colon, run by The University of 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 3 inclusion and 4 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 11 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
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 Dominic CC Foo, MBBS (85222554389, ccfoo@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity & specificity of colorectal cancer detection (time frame: within 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 11 Dec 2019; AzTrials last refreshed its copy on 6 Nov 2026.