Ignite Creation Date:
2024-05-06 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 2:25 PM
Study NCT ID:
NCT05255588
Status:
RECRUITING
Last Update Posted:
2023-11-18
First Post:
2022-02-16
Brief Title:
A Stool DNA-based SDC2 Methylation Test for the Early Detection of Colorectal Cancer
Sponsor:
Genomictree Inc
Organization:
Genomictree Inc
Study Overview
Official Title:
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:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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 40 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 qMSPLTE-qMSP
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None