- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04194879
Effectiveness of Multi-target FIT-DNA Analysis as a Colorectal Cancer Screening Test
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Dominic CC Foo, MBBS
- Phone Number: 85222554389
- Email: ccfoo@hku.hk
Study Contact Backup
- Name: Tak Ka Man
- Email: tkman@hku.hk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
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.
Other Names:
|
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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
within 3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dominic CC Foo, MBBS, The University of Hong Kong
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Adenoma
Other Study ID Numbers
- UW 19-784
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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