Clinical trial · Observational
The Diagnostic Accuracy of Using Faecal-DNA Test (COLOSAFE) for Colorectal Cancer Screening
NCT04030637CI-TRIAL-00039696unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate the sensitivity and specificity of the test kit "COLOSAFE' in Hong Kong
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| To Evaluate the Sensitivity and Specificity of a Test Kit in Hong Kong | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (3)
- label
- CRC cases
- description
- samples will be collected from subjects with known diagnosis of colorectal cancer
- label
- Healthy cases
- description
- samples will be collected from healthy subjects with normal colonoscopy findings
- label
- Cases with pathologies
- description
- samples will be collected from subjects whose colonoscopies showed other pathologies (e.g. inflammatory polyps, adenomas, diverticular diseases)
Primary outcomes (1)
- measure
- Accuracy of COLOSAFE
- timeFrame
- 1 year
- description
- Sensitivity, specificity, positive predictive value and negative predictive value in detection of CRC by COLOSAFE
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
- Maximum age
- 79 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.