Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2025-12-28 @ 3:27 AM
Study NCT ID:
NCT01260168
Status:
COMPLETED
Last Update Posted:
2015-05-13
First Post:
2010-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multi-marker Stool Test for Detection of Colorectal Neoplasia: Marker Panel Selection and Technical Development Studies
Sponsor:
Exact Sciences Corporation
Organization:
Study Overview
Official Title:
Multi-marker Stool Test for Detection of Colorectal Neoplasia: Marker Panel Selection and Technical Development Studies
Status:
COMPLETED
Status Verified Date:
2015-05
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 objective of this study is to confirm the sensitivity of a stool DNA test for detection of colorectal cancer and pre-cancer.
Another objective is to provide anonymous, clinically characterized specimens for a bio-repository for future colorectal cancer-related test development.
Another objective is to provide anonymous, clinically characterized specimens for a bio-repository for future colorectal cancer-related test development.
Detailed Description:
Patients who have been recently diagnosed with colo-rectal cancer or pre-cancer will be asked to submit a stool sample(s)(at least 7 days AFTER colonoscopy) and will have the option of submitting blood and tissue samples for future colo-rectal cancer-related test development.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: