Clinical Validation of Stool DNA-based SDC2 Methylation Test for Colorectal Cancer Detection

Clinical Study for the Validation of Real Time qPCR for SDC2 Methylation in Stool DNA for Early Detection of Colorectal Cancer

Pivotal trials of SDC2 methylation biomarker test in stool DNA to estimate clinical sensitivity and specificity in detection of colorectal cancer.

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.

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