Biomarker Expression in Patients With ACTH-Dependent Cushing's Syndrome Before and After Surgery

Completed

Conditions studied: Cushing's Syndrome

In brief

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.

Key facts

Study ID

NCT02922257

Run by

Corcept Therapeutics

People needed

26

Starts

2016-11-01

Expected to finish

2018-10-30

Last updated by the study team

2019-01-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 18 years of age.
• Has a documented diagnosis of ACTH-dependent, endogenous Cushing's syndrome and is scheduled for curative surgery.
• Must be able to comprehend and sign an approved Informed Consent Form (ICF) and other applicable study enrollment documents.

You may not qualify if…

• Plans for pre-operative and/or intra-operative use of glucocorticoid ("steroid cover").
• Use any of the following treatments for Cushing's syndrome, as specified:
• 4 weeks prior to first specimen collection and/or during the study period.
• Adrenostatic medications (metyrapone, ketoconazole, fluconazole, aminoglutethimide, LCI699 or etomidate etc).
• Short-acting somatostatin analogs (octreotide, pasireotide).
• 6 weeks prior to first specimen collection and/or during the study period.
• o Mifepristone.
• 8 weeks prior to first specimen collection and/or during the study period.
• o Neuromodulator drugs that act at the hypothalamic-pituitary level: serotonin antagonists (cyproheptadine, ketanserin, retanserin), dopamine agonists (bromocriptine, cabergoline), gamma-aminobutyric acid agonists (sodium valproate), and somatostatin receptor ligands (octreotide long-acting release [LAR], pasireotide LAR, lanreotide).
• Concomitant use of the following due to their potential to stimulate the expression of FKBP5:
• Testosterone or other steroid hormone analogues.
• Oral contraceptives or hormonal replacement therapy.
• History of illness that the Principal Investigator (PI) considers could interfere with or affect the conduct, results, and/or completion of the clinical trial.
• Pregnancy or breastfeeding.

Where it is running

• Study site — Los Angeles, California, United States
• Study site — Rochester, Minnesota, United States
• Study site — Cleveland, Ohio, United States
• Study site — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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