Colorectal Cancer, Healthy, Other Cancers, Polyps
Conditions
Keywords
Syndecan 2, Methylation biomarker, Colorectal cancer, EarlyTect Colon Cancer test
Brief summary
Pivotal trials of SDC2 methylation biomarker test in stool DNA to estimate clinical sensitivity and specificity in detection of colorectal cancer.
Detailed description
The purpose of this study is to validate the clinical performance of EarlyTect Colon Cancer test which is measuring Syndecan 2 methylation status in stool DNA to detect CRC. Syndecan 2 (SDC2) is a newly developed methylation biomarker for colorectal cancer diagnosis. Methylation status of SDC2 gene in stool DNA is determined by methylation specific qPCR. Sensitivity and specificity will be determined by comparing Stool DNA test from healthy subjects, CRC patients, and other group including polyps and other diseases.
Interventions
DEVICEEarlyTect Colon Cancer
SDC2 methylation assay by qPCR using EarlyTect Colon Cancer kit
Sponsors
Severance Hospital
Genomictree, Inc.
Study design
Observational model
CASE_CONTROL
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* sample information is complete, including sample number, gender, family history, stage of cancer, treatment history, and other disease information * the CRC patient who has not any treatment (surgery, chemotherapy, or radiation) * non-CRC patient who has not received any treatment (surgery, chemotherapy, or radiation) within the last 6 months * all of above conditions are satisfied, and any one of below can be applicable; 1) confirm to be CRC with colonoscopy and/or pathological examination, 2) confirm to be inflammatory or ulcerative bowel diseases or benign hyperplastic polyp, 3) confirm to be gastrointestinal or liver cancers who are not CRC, 4) schedule to receive colonoscopy and additional confirmation test for CRC with agreement to provide the test results.
Exclusion criteria
any one of below can be applicable; * the patient information is not complete and/or does not satisfy inclusion criteria * the sample information is not complete and/or does not satisfy inclusion criteria * the CRC patient who has history of colorectal cancer surgery, chemotherapy, or any other treatment * non-CRC patient who received any chemotherapy within the last 6 months * the patient who has limited ability or are vulnerable to accept clinical trial agreement * the patient who is judged as not suitable for clinical trial including a psychiatric disorder by a physician
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical performance of EarlyTect Colon Cancer to detect colorectal cancer | 1.5 years | Sensitivity and specificity of EarlyTect Colon Cancer to detect colorectal cancer (sensitivity: the ratio of positive cases in all CRC cases, specificity: the ratio of negative cases in all healthy controls) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Positive ratio of SDC2 methylation in polyps | 1.5 years | the ratio of SDC2 methylation positive in polyps |
| Positive ratio of SDC2 methylation in other cancers | 1.5 years | the ratio of SDC2 methylation positive in other cancers |
Countries
South Korea
Outcome results
None listed