None listed
Conditions
Interventions
None listed
Sponsors
Genomictree
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Individuals who voluntarily agreed to participate in this clinical study 2. Adults aged 40 years or older who visited the clinic within the past 3 months with a positive FIT result 3. Individuals who plan to undergo colonoscopy within 6 months after providing consent
Exclusion criteria
Exclusion criteria: 1.Individuals who do not consent to participate in this clinical study 2. Individuals under 40 years of age 3. Individuals who do not plan to undergo colonoscopy within 6 months after providing consent 4. History of colorectal cancer 5. History of colorectal resection 6. History or family history of hereditary colorectal cancer or hereditary colorectal polyposis syndromes: Lynch syndrome (HNPCC), familial adenomatous polyposis, MUTYH-associated polyposis, juvenile polyposis syndrome, Peutz-Jeghers syndrome, serrated polyposis syndrome, etc. 7. Patients with inflammatory bowel disease (Crohn’s disease, ulcerative colitis, or intestinal Behçet’s disease) 8. Participation in another clinical trial within the past 30 days 9. Individuals deemed unsuitable for participation in this study for medical reasons, as determined by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic accuracy of FIT and EarlyTect® Colon Cancer test for advanced colorectal neoplasia | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of sensitivity, specificity, positive predictive value, and negative predictive value of FIT and EarlyTect® Colon Cancer test for the diagnosis of advanced colorectal neoplasia;Comparison of sensitivity, specificity, positive predictive value, and negative predictive value of FIT and EarlyTect® Colon Cancer test for the diagnosis of colorectal cancer;Comparison of sensitivity, specificity, positive predictive value, negative predictive value, and diagnostic accuracy of FIT and EarlyTect® Colon Cancer test for advanced colorectal neoplasia and colorectal cancer across subgroups stratified by initial FIT level;Comparison of sensitivity, specificity, positive predictive value, negative predictive value, and diagnostic accuracy of FIT and EarlyTect® Colon Cancer test for advanced colorectal neoplasia and colorectal cancer in a high-risk subgroup (APCS score = 4);Evaluation of the sensitivity of FIT and EarlyTect® Colon Cancer test for the diagnosis of advanced colorectal adenoma, advanced serrated lesion, and non-advanced colorectal adenoma;Comparison of diagnostic accuracy and diagnostic missing rate between initial FIT results and additional tests for advanced colorectal neoplasia and colorectal cancer | — |
Countries
Korea, Republic of
Contacts
Public ContactSu Young Kim
Yonsei University, Wonju Severance Christian Hospital
Outcome results
None listed