TerminatedPhase 2

Study of Adrenalectomy Versus Observation for Subclinical Hypercortisolism

Stopped: Study was closed due to low accrual.

United States4 participantsStarted 2013-11-27

Plain-language 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.

Who can participate

Age range18 Years – 99 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* 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).

What they're measuring

Proportion of Patients That Have Normalization and/or Improvement of Metabolic Complications After Adrenalectomy

Timeframe: Assessed at 6 months

Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)

Timeframe: Date treatment consent signed to date off study, approximately 39 months and 27 days

Trial details

NCT IDNCT02001051

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2017-08-22

Results submitted2018-04-04

View on ClinicalTrials.gov More Subclinical Hypercortisolism trials