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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02922257
Recruitment Status : Completed
First Posted : October 4, 2016
Last Update Posted : January 24, 2019
Sponsor:
Information provided by (Responsible Party):
Corcept Therapeutics

Study Description
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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.

Condition or disease
Cushing's Syndrome

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], 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 Design
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Study Type : Observational
Actual Enrollment : 26 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective, Non-interventional Clinical Study of Biomarker Expression in Patients With ACTH-Dependent Cushing's Syndrome Before and After Surgery
Actual Study Start Date : November 2016
Actual Primary Completion Date : October 30, 2018
Actual Study Completion Date : October 30, 2018

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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
RNA extracted from blood samples

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • ≥ 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.

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Corcept Therapeutics
Investigators
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Study Director: Andreas Moraitis, M.D. Corcept Therapeutics
More Information
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Responsible Party: Corcept Therapeutics
ClinicalTrials.gov Identifier: NCT02922257    
Other Study ID Numbers: FKBP5-700
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: January 24, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Cushing Syndrome
Syndrome
Disease
Pathologic Processes
 Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases