Biomarker Expression in Patients With ACTH-Dependent Cushing's Syndrome Before and After Surgery
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|ClinicalTrials.gov Identifier: NCT02922257|
Recruitment Status : Active, not recruiting
First Posted : October 4, 2016
Last Update Posted : July 13, 2018
|Condition or disease|
This study will investigate the potential for FK506 binding protein 5 (FKBP5) (and other gene expression markers, for example pentraxin 3 [PTX-3], serum/glucocorticoid regulated kinase 1 [SGK1], and glycogen synthase kinase 3 beta [GSK3b]) to be developed as a biomarker for use in diagnosis of Cushing's syndrome, assessment of effectiveness of medical or surgical treatment, and detection of relapse of endogenous Cushing's syndrome after surgery.
The primary study hypothesis is that FKBP5 levels are elevated in patients with Cushing's 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 Cushing's syndrome scheduled for curative surgery and followed until relapse of endogenous Cushing's syndrome or up to 3 years post-surgery. No study medication will be given.
|Study Type :||Observational|
|Actual Enrollment :||26 participants|
|Official Title:||Prospective, Non-interventional Clinical Study of Biomarker Expression in Patients With ACTH-Dependent Cushing's Syndrome Before and After Surgery|
|Study Start Date :||November 2016|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||September 2018|
- Gene expression levels [ Time Frame: three years ]Change in FKBP5 expression levels from baseline to after surgical treatment but prior to glucocorticoid replacement therapy
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02922257
|United States, California|
|Los Angeles, California, United States, 90048|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|United States, Washington|
|Seattle, Washington, United States, 98122|
|Study Director:||Andreas Moraitis, M.D.||Corcept Therapeutics|