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).
Study Type
OBSERVATIONAL
Enrollment
2,358
A highly accurate and sensitive real time PCR employing Linear Target Enrichment and Quantitative Methylation-Specific PCR (LTE/qMSP) for measuring SDC2 methylation in stool DNA to detect CRC.
Soon Chun Hyang University Hospital Seoul
Seoul, South Korea
Sensitivity and specificity of the EarlyTect® CRC test for detecting CRC compared to the colonoscopy, both in terms of detecting CRC.
The reference method is the colonoscopy, and lesions will be assessed histopathologically. EarlyTect® CRC test includes a measurement of SDC2 methylation and COL2A1 as a DNA control. SDC2 methylation in stool DNA will be assessed quantitatively by LTE/qMSP. The results will be dichotomized by the CT (cycle threshold) cutoff value as either positive or negative. Sensitivity = 100\*(positive SDC2 methylation test/positive colonoscopy), Specificity = 100\*(negative SDC2 methylation test/negative colonoscopy).
Time frame: 18 months
Sensitivity of EarlyTect® CRC for detecting advanced colorectal adenoma (Adenomas ≥1.0 cm, villous adenomas or high-grade dysplasia)
Sensitivity for detecting adenomas ≥1.0 cm * Sensitivity of EarlyTect® CRC for detecting villous adenomas * Sensitivity of EarlyTect® CRC for detecting high-grade dysplasia
Time frame: 18 months
Sensitivity of EarlyTect® CRC for detecting advanced colorectal neoplasm
Sensitivity for detecting adenomas ≥1.0 cm
Time frame: 18 months
Sensitivity of EarlyTect® CRC for detecting non-advanced adenomas
Sensitivity for detecting non-adenomas \<1.0 cm
Time frame: 18 months
Sensitivity and specificity of combined FIT and EarlyTect® CRC tests in detecting CRC
Sensitivity and specificity of combined FIT and EarlyTect® CRC tests in detecting CRC
Time frame: 18 months
Sensitivity of EarlyTect® CRC for detecting advanced colorectal serrated lesions
Sensitivity of EarlyTect® CRC for detecting advanced colorectal serrated lesions
Time frame: 18 months
Clinical specificity of EarlyTect® CRC when patients with non-advanced adenomas and non-advanced colorectal serrated lesions are included in control group
Clinical specificity of EarlyTect® CRC when patients with non-advanced adenomas and non-advanced colorectal serrated lesions are included in control group
Time frame: 18 months
Clinical sensitivity of the EarlyTect® CRC for detecting Tis
Clinical sensitivity of the EarlyTect® CRC for detecting colorectal cancer with Tis
Time frame: 18 months
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