Evaluation for the clinical sensitivity and specificity of stool DNA-based SDC2 methylation test for the early diagnosis of colorectal cancer
- Conditions
- Neoplasms
- Registration Number
- KCT0007180
- Lead Sponsor
- Genomictree
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 2358
Sex: Both
Age: Adults aged = 40 years
? Individuals who agree to voluntarily sign an informed consent prior to the initiation of screening
? 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.
? 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 undergone colonoscopy, flexible sigmoidoscopy, double-contrast barium enema, or virtual (CT-based) colonoscopy within the
previous 5 years
? Subjects who have had a positive FIT or fecal occult blood test within the previous six months
? Subjects who have had a prior history of malignancy
? Subjects who have had a prior history of colorectal resection
? Subjects who have had overt rectal bleeding or melena within the previous one month
? 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
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ? Sensitivity and specificity of the EarlyTect® CRC test for early diagnosis of colorectal cancer.
- Secondary Outcome Measures
Name Time Method ? Non-inferiority test of colorectal cancer diagnostic sensitivity of EarlyTect® CRC compare with FIT;? Sensitivity of EarlyTect® CRC for detecting advanced colorectal adenoma ;? Sensitivity of EarlyTect® CRC for detecting advanced colorectal neoplasm;? Sensitivity of EarlyTect® CRC for detecting non-advanced adenomas;? Sensitivity of EarlyTect® CRC for detecting serrated lesions =1.0 cm;? Sensitivity and specificity of combined FIT and EarlyTect® CRC tests in detecting CRC;? Clinical specificity of EarlyTect® CRC when patients with non-advanced adenomas are included in control group