Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06401421
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-05-02
Brief Title:
EXActDNA-003 NSABP B-64 Study of Molecular Residual Disease Detection in Breast Cancer MRD
Sponsor:
Exact Sciences Corporation
Organization:
Exact Sciences Corporation
Study Overview
Official Title:
EXActDNA-003 NSABP B-64 Breast Cancer Clinical Validation Study to Predict Recurrence of High-Risk Early Breast Cancer Treated With Neoadjuvant Therapy Using a Bespoke Circulating Tumor DNA Assay to Detect Molecular Residual Disease
Status:
RECRUITING
Status Verified Date:
2024-10
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 EXActDNA-003 study will prospectively enroll participants who are planning to undergo chemotherapy for high-risk early breast cancer who are willing to provide tissue and blood specimens for circulating tumor DNA ctDNA analysis
Participants will be followed for up to 55 years
Participants will be followed for up to 55 years
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None