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

Overview

Información sobre este estudio

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.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Rochester, Minn.

Investigador principal de Mayo Clinic

Irina Bancos, M.D.

Cerrado para la inscripción

More information

Publicaciones

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CLS-20271981

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