Trials / Completed
CompletedNCT05255588
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
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 2,358 (actual)
- Sponsor
- Genomictree, Inc. · Industry
- Sex
- All
- Age
- 40 Years
- Healthy volunteers
- Not accepted
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 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.
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 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).
Conditions
- Colorectal Cancer
- Advanced Colorectal Neoplasm
- Advanced Adenomas
- Non-neoplastic Polyps
- Non-advanced Adenomas
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | EarlyTect® CRC test | 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. |
Timeline
- Start date
- 2022-02-10
- Primary completion
- 2024-05-23
- Completion
- 2024-08-30
- First posted
- 2022-02-24
- Last updated
- 2025-04-03
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT05255588. Inclusion in this directory is not an endorsement.