Ignite Creation Date:
2024-05-06 @ 2:07 PM
Last Modification Date:
2024-10-26 @ 1:25 PM
Study NCT ID:
NCT04221854
Status:
UNKNOWN
Last Update Posted:
2020-02-18
First Post:
2020-01-06
Brief Title:
Stool-based SDC2 DNA Methylation Test for the Detection of Colorectal Advanced Adenomatous Polyps and Cancer
Sponsor:
Sixth Affiliated Hospital Sun Yat-sen University
Organization:
Sixth Affiliated Hospital Sun Yat-sen University
Study Overview
Official Title:
Stool-based SDC2 DNA Methylation Test vs Fecal Immunochemical Test on the Detection of Colorectal Advanced Adenomatous Polyps and Cancer in Chinese Population A Multi-central Randomized Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2020-02
Last Known Status:
RECRUITING
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 is to compare the performance of Stool-based SDC2 DNA Methylation Test and commercially available Fecal Immunochemical TestFIT on the detection rate of advanced adenomatous polyps and colorectal cancer in Chinese population Subjects with positive results in either test will receive colonoscopy Lesions will be confirmed as malignant or precancerous by colonoscopy and histopathologic examination
Detailed Description:
A large cohort of participants will be asked to collect stool sample for either Stool-based SDC2 DNA Methylation Test or Fecal Immunochemical Test Subjects who have positive results will undergo colonoscopy within 6 months
Representative histopathology slides from tissue biopsied or excised during colonoscopy and those from subsequent definitive surgery may be retrieved in order to be evaluated by pathologists to confirm the diagnosis and staging
Representative histopathology slides from tissue biopsied or excised during colonoscopy and those from subsequent definitive surgery may be retrieved in order to be evaluated by pathologists to confirm the diagnosis and staging
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