Clinical trial: Collecting Information About Treatment Results for Patients With Cushing's Syndrome (NCT03364803)

Eligibility criteria:
Inclusion Criteria:

          -  Age 14 or older

          -  Active or treated Cushing's (due to pituitary, ectopic, or adrenal tumor)

          -  The diagnosis of CS will be made by the PI, based on the below Endocrine Society
             guidelines, the patient's clinical presentation, and the PI's judgment.

             ° Diagnostic criteria for pituitary CD are according to the Endocrine Society
             guidelines and include: Elevated 24-hour urinary free cortisol (UFC), normal or
             elevated plasma ACTH, elevated midnight salivary cortisol levels, or classic
             dexamethasone suppression testing for CD (morning cortisol > 5 ug/dL after 1 mg
             overnight of classic 2-day low dose test) and a pituitary lesion on MRI. If patient
             does not have any of these results, pathology of ACTH tumor may confirm presence of
             disease.

          -  For pituitary patients, if the patient demonstrates non-classic testing or no
             pituitary lesion is seen on MRI then petrosal sinus sampling or positive surgical
             pathology will be used to confirm pituitary source of Cushing's. Clinical or
             biochemical remission after surgery will also confirm pituitary source.

          -  Ectopic Cushing's will be confirmed by petrosal sinus sampling and appropriate imaging
             tests, or positive surgical pathology.

          -  Adrenal Cushing's will be confirmed by a suppressed plasma ACTH value and
             identification of an adrenal lesion on CT or MRI, or positive surgical pathology.

          -  In lieu of MRI, surgical, or laboratory reports, physician's assessment note including
             mention of results will also be used as source for eligibility purposes.

        Exclusion Criteria:

          -  Patients with a diagnosis of iatrogenic Cushing's.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 14 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