Ignite Creation Date:
2024-05-06 @ 3:05 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04515082
Status:
UNKNOWN
Last Update Posted:
2020-08-18
First Post:
2020-08-13
Brief Title:
Colorectal Cancer Screening Using Stool DNA-based SDC2 and SFRP2 Methylation Test in China
Sponsor:
Changhai Hospital
Organization:
Changhai Hospital
Study Overview
Official Title:
Colorectal Cancer and Advanced Precancerous Neoplasm Screening Using Stool DNA-based SDC2 and SFRP2 Methylation Test in China a Multi-Center Study
Status:
UNKNOWN
Status Verified Date:
2020-08
Last Known Status:
NOT_YET_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 determine sensitivity specificity positive predictive value and negative predictive value of a bi-target stool DNA testing the methylation status of SDC2 and SFRP2 for colorectal cancer and advanced precancerous neoplasmincluding advanced adenoma and advanced serrated lesions screening using colonoscopy as the reference method Lesions will be confirmed as malignant or precancerous by histopathologic examination
The secondary objective is to compare the performance of the bi-target stool DNA testing to a commercially available fecal immunochemical test FIT assay both with respect to cancer and advanced precancerous neoplasm Lesions will be confirmed as malignant or precancerous by colonoscopy and histopathologic examination
The secondary objective is to compare the performance of the bi-target stool DNA testing to a commercially available fecal immunochemical test FIT assay both with respect to cancer and advanced precancerous neoplasm Lesions will be confirmed as malignant or precancerous by colonoscopy and histopathologic examination
Detailed Description:
This study is a multi-center diagnostic test led by the National Clinical Research Center for Digestive Disease Shanghai Department of Gastroenterology Changhai Hospital NavySecond Military Medical University which is conducted at about 30 digestive endoscopy centers nationwide in China with the expectation of including approximately 4800 patients Subjects willing to conduct colonoscopy examination will be asked to collect stool sample prior to bowl preparation for stool DNA test and commercially available FIT assay The basic characteristics of subjects bowel preparation method and quality and related information of colonoscopy are recorded in detail Colonoscopy and histopathologic examination are used as reference
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