Status:
COMPLETED
A Stool DNA-based SDC2 Methylation Test for the Early Detection of Colorectal Cancer
Lead Sponsor:
Genomictree, Inc.
Collaborating Sponsors:
Soon Chun Hyang University
Gangnam Severance Hospital
Conditions:
Colorectal Cancer
Advanced Colorectal Neoplasm
Eligibility:
All Genders
40+ years
Brief Summary
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 obj...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 10 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 30 2024
Estimated Enrollment :
2358 Patients enrolled
Trial Details
Trial ID
NCT05255588
Start Date
February 10 2022
End Date
August 30 2024
Last Update
April 3 2025
Active Locations (1)
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1
Soon Chun Hyang University Hospital Seoul
Seoul, South Korea