A Stool DNA-based SDC2 Methylation Test for the Early Detection of Colorectal Cancer

A Multicenter, Single-blind, Prospective Clinical Trial to Evaluate the Clinical Performance of EarlyTect® CRC Test for the Early Detection of Colorectal Cancer in the Stool DNA From High-risk Group

The primary objective of this clinical trial is to determine the sensitivity and specificity of the EarlyTect® CRC test for detecting CRC, using colonoscopy as the reference method.

The secondary objective is to compare the clinical performance of EarlyTect® CRC test with a commercially available Fecal Immunochemical Test (FIT), with respect to CRC. By histopathological examination, lesions identified during colonoscopy will be confirmed as malignant or precancerous by histological examination.

A multicenter, single-blind, prospective clinical trial is being conducted to evaluate the clinical performance of EarlyTect® CRC test. Subjects who are at high-risk (Asia Pacific Colorectal Screening Score ≥4.0) of developing CRC who are eligible for inclusion criteria will be asked to collect a stool sample and EarlyTect® CRC and FIT tests will be performed. For confirmation of the diagnosis and tumor staging, representative histopathology slides obtained from curative surgery and representative histopathology slides from tissue biopsied or excised during colonoscopy may be retrieved and examined by the central pathology laboratory. Methylation status of SDC2 in stool DNA is measured by a highly accurate and sensitive real time PCR that employs Linear Target Enrichment (LTE) and quantitative Methylation-Specific PCR (qMSP)(LTE-qMSP).

Inclusion Criteria:

Subjects enrolled into the study must meet the following criteria:

• Individuals who agree to voluntarily sign an informed consent prior to the initiation of screening
• Adults aged ≥ 40 years
• Subjects who are at high-risk (Asia Pacific Colorectal Screening (APCS) Score: 4.0~7.0) of developing CRC
• Subjects who are able and willing to undergo colonoscopy screening within 12 months of consent among individuals who reserved a visit in the division of gastroenterology or health check-up.

Exclusion Criteria:

Subjects will be excluded from enrolling into the study if any of the following criteria are met:

• Individuals who do not agree to voluntarily sign an informed consent prior to the initiation of screening
• Adults aged < 40 years
• Subjects who are not at high-risk (APCS Score ≤ 3.0) of developing CRC
• Subjects who will not undergo colonoscopy screening within 12 months of consent
• Subjects who have had a positive FIT or fecal occult blood test within the previous 2 weeks
• Colorectal cancer patients who did not underwent curative treatment
• Subjects who have had a prior history of colorectal resection
• Subjects who have had overt rectal bleeding or melena within the previous 2 weeks
• Subjects who have a family history or a prior history of hereditary CRC or colorectal neoplasm: Lynch syndrome (HNPCC), familial adenomatous polyposis, MUTYH-associated polyposis, Juvenile polyposis syndrome, Peutz-Jeghers syndrome, and serrated polyposis syndrome, etc.
• Subjects who have inflammatory bowel diseases including Crohn's disease, ulcerative colitis or Behcet disease
• Subjects who participated in any "interventional" clinical study within the previous 30 days
• Subject has any condition which, in the opinion of the medical staff should preclude participation in the study