Status:
UNKNOWN
The Diagnostic Accuracy of Using Faecal-DNA Test (COLOSAFE) for Colorectal Cancer Screening
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
To Evaluate the Sensitivity and Specificity of a Test Kit in Hong Kong
Eligibility:
All Genders
45-79 years
Brief Summary
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) los...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 11 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 28 2020
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT04030637
Start Date
February 11 2019
End Date
February 28 2020
Last Update
July 24 2019
Active Locations (1)
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1
Prince of Wales Hospital
Hong Kong, Hong Kong