Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

Background:

- Adrenal incidentalomas are common and found in approximately 4-7% of the population.

- About 0.6 to 25% of patients with an adrenal incidentaloma are found to have subclinical hypercortisolism: 2.3% develop subclinical hypercortisolism during follow up and 0.6% develop clinical hypercortisolism during follow up.

- Subclinical hypercortisolism is defined as biochemical excess of cortisol without signs and symptoms of overt hypercortisolism but may be associated with metabolic complications or disease progression and malignancy.

- Overt signs and symptoms of hypercortisolism include facial plethora, easy bruising, violaceous striae, and proximal muscle weakness.

- Several studies suggest that subclinical hypercortisolism may lead to long term consequences such as diabetes, hypertension, hypercholesterolemia, obesity, and osteoporosis.

- Thus, patients with subclinical hypercortisolism may benefit from operative intervention to halt or reverse metabolic complications associated with the disease and the risk of malignant progression.

- The optimal management of patients with subclinical hypercortisolism and adrenal incidentalomas is controversial and no large randomized trial has been conducted.

- We hypothesize that operative treatment would reduce the risk of long term complications of subclinical hypercortisolism and malignant progression, and propose a prospective randomized trial comparing nonoperative and operative management of subclinical hypercortisolism in patients with an adrenal neoplasm.

Objectives:

Primary Endpoints:

-To determine whether unilateral adrenalectomy in patients diagnosed with subclinical hypercortisolism and adrenal neoplasm results in normalization and/or improvement of hypertension as assessed by reduction in pharmacotherapy and/or normalization of blood pressure (systolic pressure <=140 and diastolic pressure <=90), diabetes as assessed by reduction or elimination of pharmacotherapy and/or improvement in A1C to <6.5%, osteoporosis by increase in bone formation markers indicative of increased bone formation, hypercholesterolemia as assessed by a reduction or elimination of pharmacotherapy and/or reduction in low density lipoprotein (LDL) levels to risk-stratified goal levels as defined by Adult Treatment Panel III (ATP III), and/or overweight or obesity as assessed by a 10 percent reduction in weight at 6 months.

Eligibility:

- 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 adrenocorticotrophic 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 based on standard clinical practice.

Design:

- Prospective randomized study comparing adrenalectomy versus observation.

- Patients assigned to the operative arm will undergo adrenalectomy and then followed postoperatively for normalization and/or improvement of metabolic complications associated with hypercortisolism and histologic examination of the resected tumor.

- Patients assigned to the non-operative arm will be monitored for possible complications associated with hypercortisolism for six months, at which point they will cross-over to the operative intervention arm.

- Patients with bilateral adrenal neoplasms will have the larger adrenal neoplasm used as the primary lesion responsible for subclinical hypercortisolism.

- Demographic, clinical, laboratory and pathologic data will be collected for each patient participant. Data will be securely stored in a computerized database.

- Patients will have biochemical testing to determine if their adrenal neoplasm is functioning or nonfunctioning.

- Projected accrual will be 15 to 20 patients per year for a total of 5 years. Thus, we anticipate accruing 62 patients on this protocol. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02001051
Study type Interventional
Source National Institutes of Health Clinical Center (CC)
Contact
Status Terminated
Phase Phase 2
Start date November 27, 2013
Completion date February 26, 2018

See also
  Status Clinical Trial Phase
Recruiting NCT06050057 - Surgical Treatment of Adrenal Diseases- Laparoscopic vs. Robotic-assisted Adrenalectomy
Recruiting NCT05881005 - NAC- NAFLD And Cushing N/A
Recruiting NCT00669266 - Adrenal Tumors - Pathogenesis and Therapy
Terminated NCT03379363 - Retrospective Chart Review Study of Pediatric Patients Treated With Korlym for Cushing Syndrome
Recruiting NCT06008184 - Real-time Monitoring of Cortisol - Comparison of Cortisol Levels in Four Biological Fluids
Recruiting NCT05911620 - Evaluation of the Severity of Hepatic Fibrosis by Magnetic Resonance Elastography in the Diagnosis of Endogenous Hypercorticism N/A
Completed NCT02934399 - Dynamic Hormone Diagnostics in Endocrine Disease
Recruiting NCT04045015 - Liquorice and Salivary Cortisol N/A
Recruiting NCT05804669 - A Study to Evaluate the Safety and PK of CRN04894 for the Treatment of Cushing's Syndrome Phase 1/Phase 2
Enrolling by invitation NCT03474237 - A Prospective Cohort Study for Patients With Adrenal Diseases
Recruiting NCT03343470 - The Circadian Rhythm in CusHing SyndrOme in Active Phase and dUring RemiSsion (TheHOURS)
Recruiting NCT03364803 - Collecting Information About Treatment Results for Patients With Cushing's Syndrome
Completed NCT03697109 - A Study of the Efficacy and Safety of Relacorilant in Patients With Endogenous Cushing Syndrome Phase 3
Enrolling by invitation NCT03604198 - Extension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome Phase 2
Completed NCT05347979 - Effect of Relacorilant on the Pharmacokinetics of the Sensitive P-glycoprotein Substrate Dabigatran Etexilate in Healthy Participants Phase 1
Recruiting NCT01382420 - Long-term Beneficial Metabolic Effects of Adrenalectomy in Subclinical Cushing's Syndrome of Adrenal Incidentaloma N/A
Completed NCT00001849 - New Imaging Techniques in the Evaluation of Patients With Ectopic Cushing Syndrome Phase 2
Recruiting NCT06229405 - Development of Clinical Evidence for Optimal Management of Adrenal Diseases Based on Real-World Data
Recruiting NCT03211624 - Quality of Life, Fatigue and Cognitive, Affective and Emotional Dysfunction in Patients With Cushing's Syndrome
Terminated NCT05456997 - Metabolic Myopathy in Endocrinopathy