Ignite Creation Date:
2024-05-06 @ 9:11 AM
Last Modification Date:
2024-10-26 @ 12:11 PM
Study NCT ID:
NCT02922257
Status:
COMPLETED
Last Update Posted:
2019-01-24
First Post:
2016-09-27
Brief Title:
Biomarker Expression in Patients With ACTH-Dependent Cushings Syndrome Before and After Surgery
Sponsor:
Corcept Therapeutics
Organization:
Corcept Therapeutics
Study Overview
Official Title:
Prospective Non-interventional Clinical Study of Biomarker Expression in Patients With ACTH-Dependent Cushings Syndrome Before and After Surgery
Status:
COMPLETED
Status Verified Date:
2019-01
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:
None
Brief Summary:
This study will investigate the potential for FK506 binding protein 5 FKBP5 and other gene expression markers for example pentraxin 3 PTX-3 serumglucocorticoid regulated kinase 1 SGK1 and glycogen synthase kinase 3 beta GSK3b to be developed as a biomarker for use in diagnosis of Cushings syndrome assessment of effectiveness of medical or surgical treatment and detection of relapse of endogenous Cushings syndrome after surgery
Detailed Description:
This study will investigate the potential for FK506 binding protein 5 FKBP5 and other gene expression markers for example pentraxin 3 PTX-3 serumglucocorticoid regulated kinase 1 SGK1 and glycogen synthase kinase 3 beta GSK3b to be developed as a biomarker for use in diagnosis of Cushings syndrome assessment of effectiveness of medical or surgical treatment and detection of relapse of endogenous Cushings syndrome after surgery
The primary study hypothesis is that FKBP5 levels are elevated in patients with Cushings syndrome and these levels decrease after successful surgical treatment
This is a non-randomized specimen collection study with pre- and post-surgery follow-up periods This study will be performed in patients with adrenocorticotropic hormone ACTH-dependent Cushings syndrome scheduled for curative surgery and followed until relapse of endogenous Cushings syndrome or up to 3 years post-surgery No study medication will be given
The primary study hypothesis is that FKBP5 levels are elevated in patients with Cushings syndrome and these levels decrease after successful surgical treatment
This is a non-randomized specimen collection study with pre- and post-surgery follow-up periods This study will be performed in patients with adrenocorticotropic hormone ACTH-dependent Cushings syndrome scheduled for curative surgery and followed until relapse of endogenous Cushings syndrome or up to 3 years post-surgery No study medication will be given
Study Oversight
Has Oversight DMC:
None
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?:
None