A Study to Confirm Recurrent or Persistent Cushing's Syndrome in Patients With Signs or Symptoms of Hypercortisolemia

Study Overview
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Brief Summary
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This is an observational study to confirm the presence of recurrent or persistent endogenous Cushing's syndrome in patients who have had primary surgical and/or radiation therapy for Cushing's disease and continue to manifest symptoms and signs of hypercortisolemia.

Official Title
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A Study to Confirm the Presence of Recurrent or Persistent Cushing's Syndrome in Patients With Clinical Signs or Symptoms of Hypercortisolemia Who Have Been Treated for Cushing's Disease

Conditions
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Cushing's Syndrome

Intervention / Treatment
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* Drug: Cushing's syndrome confirmation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are at least 18 years of age. Have a presumptive diagnosis of Cushing's disease (Cushing's syndrome due to an ACTH secreting pituitary tumor). Have previously had pituitary surgery and/or pituitary radiation with the intent of curing or treating Cushing's disease. Have clinical symptoms and signs of hypercortisolism. Are able to provide written informed consent. Are expected to complete the study. Exclusion Criteria: Are surgical candidates for pituitary surgery or have had pituitary surgery within 8 weeks before screening. Have taken any medication that may interfere with protocol testing procedures within 30 days of initial screening (phenobarbital, phenytoin, carbamazepine, oxcarabazepine, primidone, rifampin, rifapentine, rifabutin, ethosuximide, pioglitazone, efavirenz, neviparine, modafinil, St. Johns wort, glucorticoids, estrogen containing oral contraceptives). Have received investigational treatment (drug, biologic agent or device) within 30 days of screening. Have a non-endogenous source of hypercortisolemia such as factitious hypercortisolemia (exogenous source of glucocorticoid, iatrogenic Cushing's syndrome), factitious or therapeutic use of ACTH. Have Pseudo-Cushing's syndrome. Subjects with suspected Pseudo-Cushing's syndrome such as those with severe obesity, major depression or a history of alcoholism. Uncontrolled, clinically significant hypothyroidism or hyperthyroidism. Have renal failure as defined by a serum creatinine of 202 mg/dL. Elevated total bilirubin (>1.5x ULN), elevated ALT(>3x ULN) or AST (>3x ULN).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Patients with presumed Cushing's disease who have failed pituitary surgery and/or radiation and require medical treatment for recurrent or persistent Cushing's syndrome. | Drug: Cushing's syndrome confirmation<br> <br> * Other names: Provide access to standard test procedures.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To confirm the presence of recurrent or persistent endogenous Cushing's syndrome in patients who have had primary surgical and/or radiation therapy for Cushing's disease and continue to manifest symptoms and signs of hypercortisolemia. |  | up to 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cushing's Disease, Cushing's Syndrome, Cushings, Pituitary, ACTH, Adrenocorticotropic hormone, Ectopic, Adrenal adenoma, Adrenal carcinoma, Adrenal autonomy, Cortisol, Hypercortisolemia, Cushinoid, Moon facies, Dorsalcervical fat, Plethora, Hirsutism, Violaceous striae, Hormone, Contraceptive, Endocrine, Cushing Syndrome, Ectopic ACTH Secretion