Ignite Creation Date:
2024-05-06 @ 3:25 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04624555
Status:
RECRUITING
Last Update Posted:
2024-05-28
First Post:
2020-11-05
Brief Title:
The Utility and Feasibility of Mt-sDNA as a Surveillance Procedure in Colorectal Cancer Survivors
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
The Utility and Feasibility of Mt-sDNA as a Surveillance Procedure in Colorectal Cancer Survivors
Status:
RECRUITING
Status Verified Date:
2024-09
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 purpose of this research study is to determine whether testing of stool for a panel of markers will enable us to detect polyps and cancer compared to standard testing
Detailed Description:
Participants who were diagnosed with Stage I-III colorectal cancer will undergo testing with mt-sDNA followed by a questionnaire about satisfaction with mt-sDNA multitarget stool DNA panel prior to their scheduled colonoscopies at years 1 and 4 after diagnosis
Participants will be asked to provide a stool sample for mt-sDNA Cologuard testing that will be collected within 90 days before their scheduled colonoscopy The kit will be given to the participant by study personnel and mailed back directly to Exact Science
Participants will be asked to provide a stool sample for mt-sDNA Cologuard testing that will be collected within 90 days before their scheduled colonoscopy The kit will be given to the participant by study personnel and mailed back directly to Exact Science
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