Clinical trial: Biomarker Expression in Patients With ACTH-Dependent Cushing's Syndrome Before and After Surgery (NCT02922257)

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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 47-year-old man comes to the office due to weight gain and fatigue.  He is not able to lift heavy objects or climb stairs. Family history is positive for DM type 2 and HTN in his father.  Blood pressure is 165/90 mm Hg and pulse is 85/min.  On physical examination, there is symmetric proximal muscle weakness of the upper and lower extremities.  Fasting plasma glucose level is 138 mg/dL and 24-hour urinary cortisol is twice the upper normal limit.  Further evaluation reveals that high-dose, but not low-dose, dexamethasone suppresses serum cortisol levels.  Serum ACTH levels are high-normal. This patient's findings are consistent with endogenous Cushing Syndrome.

Patient description (patient's own words): I'm a 47-year-old man. I went to the clinic because I had been gaining weight and had increased fatigue over the past few weeks. I was not able to lift heavy objects or even climb the stairs. My dad was diagnosed with type 2 diabetes and high blood pressure. During the exam, they took my blood pressure, which was 165/90 mm Hg, and my pulse was 85/min. They found out that I have weaknesses in both of my arms and legs. I also did a blood test on an empty stomach, and I had a glucose level of 138 mg/dL, and twice the upper normal limit of cortisol. I had high-normal levels of ACTH. The doctor said I suffer from endogenous Cushing Syndrome.

Does the patient match the trial criteria? Entailment