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

NCT02922257 | Completed

• 1 other identifier: FKBP5-700
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 4

Brief Summary

This study will investigate the potential for FK506 binding protein 5 (FKBP5) (and other gene expression markers, for example pentraxin 3 \[PTX-3\], 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.

Conditions

Cushing's Syndrome

Outcome Measures

Primary Outcomes (1)

• Gene expression levels

  Change in FKBP5 expression levels from baseline to after surgical treatment but prior to glucocorticoid replacement therapy

  three years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* ≥ 18 years of age both male and female. * Has a documented diagnosis of ACTH-dependent, endogenous Cushing's syndrome and is scheduled for curative surgery.

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:
• 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).
• weeks prior to first specimen collection and/or during the study period.
• o Mifepristone.
• 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.

Sponsors & Collaborators

• Corcept Therapeutics: lead

Study Sites (4)

Unknown Facility

Los Angeles, California, 90048, United States

Location

Unknown Facility

Rochester, Minnesota, 55905, United States

Location

Unknown Facility

Cleveland, Ohio, 44195, United States

Location

Unknown Facility

Seattle, Washington, 98122, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

RNA extracted from blood samples

MeSH Terms

Conditions

Cushing Syndrome

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Study Officials

• Andreas Moraitis, M.D.

  Corcept Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2016
• First Posted: October 4, 2016
• Study Start: November 1, 2016
• Primary Completion: October 30, 2018
• Study Completion: October 30, 2018
• Last Updated: January 24, 2019

Record last verified: 2019-01

Locations

US (4)