Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2025-12-25 @ 9:24 PM
Study NCT ID:
NCT01974856
Status:
COMPLETED
Last Update Posted:
2015-09-16
First Post:
2013-10-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Prospective Observational Study of Clinical Outcomes for the NanoString® Technologies Prosigna™ Gene Signature Assay
Sponsor:
NanoString Technologies, Inc.
Organization:
Study Overview
Official Title:
A Prospective Observational Study of Clinical Outcomes for the NanoString® Technologies, Inc. Breast Cancer Intrinsic Subtype Test
Status:
COMPLETED
Status Verified Date:
2015-09
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 primary objective of this study is to assess the extent to which the Prosigna™ Breast Cancer Prognostic Gene Signature Assay affects the medical oncologist's treatment recommendations regarding adjuvant chemotherapy and actual treatments received for patients with early-stage breast cancer.
Detailed Description:
Changes in treatment recommendations will include (1) hormonal therapy alone, (2) hormonal therapy plus chemotherapy, and (3) changes in types of chemotherapy if chemotherapy was recommended before and after the test.
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?: