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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 : Completed
First Posted : October 4, 2016
Last Update Posted : January 24, 2019
Sponsor:
Information provided by (Responsible Party):
Corcept Therapeutics

Tracking Information
First Submitted Date September 27, 2016
First Posted Date October 4, 2016
Last Update Posted Date January 24, 2019
Actual Study Start Date November 2016
Actual Primary Completion Date October 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 30, 2016)
Gene expression levels [ Time Frame: three years ]
Change in FKBP5 expression levels from baseline to after surgical treatment but prior to glucocorticoid replacement therapy
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Biomarker Expression in Patients With ACTH-Dependent Cushing's Syndrome Before and After Surgery
Official Title Prospective, Non-interventional Clinical Study of Biomarker Expression in Patients With ACTH-Dependent Cushing's Syndrome Before and After Surgery
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
RNA extracted from blood samples
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.
Condition Cushing's Syndrome
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 11, 2018)
26
Original Estimated Enrollment
 (submitted: September 30, 2016)
20
Actual Study Completion Date October 30, 2018
Actual Primary Completion Date October 30, 2018   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02922257
Other Study ID Numbers FKBP5-700
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Corcept Therapeutics
Study Sponsor Corcept Therapeutics
Collaborators Not Provided
Investigators
Study Director: Andreas Moraitis, M.D. Corcept Therapeutics
PRS Account Corcept Therapeutics
Verification Date January 2019