To Evaluate the Sensitivity and Specificity of a Test Kit in Hong Kong Clinical Trial
Official title:
The Diagnostic Accuracy of Using Faecal-DNA Test (COLOSAFE) for Colorectal Cancer Screening
To evaluate the sensitivity and specificity of the test kit "COLOSAFE' in Hong Kong
Status | Recruiting |
Enrollment | 400 |
Est. completion date | February 28, 2020 |
Est. primary completion date | January 1, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 45 Years to 79 Years |
Eligibility |
Inclusion Criteria: 1. CRC patients, individuals with normal colonoscopy findings, or patients with other colorectal pathologies; 2. Chinese subjects aged 45 to 79 years living in Hong Kong for most of the time in the past 5 years; 3. Having received colonoscopy within 8 days to 3 months before enrolment in the study); 4. Absence of medical conditions that render the subject unable to comprehend the study; 5. Willing to provide informed consent; 6. Willing to provide faecal sample for laboratory investigation in the present study. Exclusion Criteria: 1. 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); 2. Previous history of inflammatory bowel diseases or digestive cancers other than CRC; 3. History of colorectal resection for any reason other than sigmoid diverticula; 4. Had a surgery or an invasive procedure within the past 3 months; 5. Received chemotherapy or radiotherapy with the past 3 months; 6. Had participated in any interventional clinical study within the previous 30 days. |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Prince of Wales Hospital | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Accuracy of COLOSAFE | Sensitivity, specificity, positive predictive value and negative predictive value in detection of CRC by COLOSAFE | 1 year |