Study of Adrenalectomy Versus Observation for Subclinical Hypercortisolism
Condition: Subclinical Hypercortisolism; Cushing Syndrome; Adrenal Neoplasm
MeSH terms: Adrenal Gland Neoplasms; Cushing Syndrome; Adrenocortical Hyperfunction
Intervention: Adrenalectomy; Observation
Intervention description: Surgery to remove tumor when enrolled in the protocol.; Observation for 6 months prior to surgery
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Diabetes, Hypertension, Hypercholesterolemia, Obesity, and Osteoporosis.; Nonoperative and Operative Management; Adrenal Incidentalomas; Excess of Cortisol

Summary:

      Background:

      - Adrenal tumors are a common kind of tumor. Some of these secrete extra cortisol into the
      body, which can lead to diabetes, obesity, and other diseases. Some people with extra
      cortisol will show symptoms like bruising and muscle weakness. Others will show no signs.
      This is called subclinical hypercortisolism. Some of these adrenal tumors become malignant.
      Researchers want to know the best way to treat people with subclinical hypercortisolism. They
      want to know if removing the tumor by surgery reduces the long-term effects of the disease.

      Objectives:

      - To see if removing an adrenal tumor by surgery improves blood pressure, diabetes, obesity,
      osteoporosis, or cholesterol, and cancer detection.

      Eligibility:

      - Adults 18 and older with an adrenal tumor and high cortisol levels.

      Design:

        -  Participants will be screened with medical history, blood tests, and a computed
           tomography (CT) scan.

        -  Participants will have a baseline visit. They will have blood and urine tests and 7
           scans. For most scans, a substance is injected through a tube in the arm. Participants
           will lie still on a table in a machine that takes images.

        -  Participants will have surgery to remove their tumor. Some will have surgery right away.
           Some will have surgery 6 months later, after 2 follow-up appointments.

        -  Participants will have 4 follow-up visits in the first year after surgery. They will
           have 2 visits the second year, then yearly visits for 3 years. At each follow-up visit,
           they will have scans and blood tests.
    

Eligibility criteria:

        -  INCLUSION CRITERIA:

          -  An individual with an adrenal neoplasm less than 5 cm in size with biochemically
             confirmed evidence of hypercortisolism (2 out of 3: dexamethasone suppression test
             (DST) >3 mcgl/dL, elevated urine free cortisol, and/or morning adrenocorticotropic
             hormone (ACTH) <2.2 pmol/l) without overt clinical signs and symptoms.

          -  Age greater than or equal to 18 years.

          -  Adults must be able to understand and sign the informed consent document.

          -  Patients must have laboratory and physical examination parameters within acceptable
             limits by standard of practice.

        EXCLUSION CRITERIA:

          -  Biochemically and/or radiologically confirmed pheochromocytoma, hyperaldosteronism, or
             adrenocortical carcinoma.

          -  Nonfunctioning adrenal neoplasm.

          -  Pre-existing cancers and/or metastatic disease to the adrenal glands.

          -  Pregnancy and/or lactation.

          -  Lack of metabolic complications.

          -  Imaging features worrisome for malignancy (heterogeneous tumor, presence of
             calcifications, necrosis, >10 Hounsfield units on an unenhanced computed tomography
             (CT) scan, and delayed washout of contrast).