Ignite Creation Date:
2024-05-06 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05724407
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-02-13
First Post:
2023-02-02
Brief Title:
Molecular Signature for Breast Cancer
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Evaluation of the Use of a Diagnostic Assistance Tool of Prognostic and Predictive Marker Scoring System in Breast Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-01
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:
MoSi4BCa
Brief Summary:
The main objective of this study is to evaluate and compare the diagnostic performance of a diagnostic assistance tool for analysis of 5 prognostic and predictive markers of breast cancer HER2 Ki67 Index Mitoses Estrogen Hormone Receptor Hormone Progesteron receptors hormone of Progesteronereceptor integrating an automatic analysis algorithm compared to a reference gold standard defined as the rereading by at least two different anatomopathologists according to the standard method of care in order to show the non-inferiority of the automatic analysis algorithm compared to this gold standard
Detailed Description:
None
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