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

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ClinicalTrials.gov Identifier: NCT02922257
Recruitment Status : Recruiting
First Posted : October 4, 2016
Last Update Posted : August 23, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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

Study Type : Observational
Estimated Enrollment : 20 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
Study Start Date : November 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

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


Contacts
Contact: Rashi Khare CorceptStudy700@corcept.com

Locations
United States, California
Recruiting
Los Angeles, California, United States, 90048
United States, Minnesota
Recruiting
Rochester, Minnesota, United States, 55905
United States, Ohio
Recruiting
Cleveland, Ohio, United States, 44195
United States, Washington
Recruiting
Seattle, Washington, United States, 98122
Sponsors and Collaborators
Corcept Therapeutics
Investigators
Study Director: Andreas Moraitis, M.D. Corcept Therapeutics
More Information

Responsible Party: Corcept Therapeutics
ClinicalTrials.gov Identifier: NCT02922257     History of Changes
Other Study ID Numbers: FKBP5-700
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: August 23, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Syndrome
Cushing Syndrome
Disease
Pathologic Processes
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases