Study of Adrenalectomy Versus Observation for Subclinical Hypercortisolism
- 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.
- To see if removing an adrenal tumor by surgery improves blood pressure, diabetes, obesity, osteoporosis, or cholesterol, and cancer detection.
- Adults 18 and older with an adrenal tumor and high cortisol levels.
- Participants will be screened with medical history, blood tests, and a 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Randomized Control Trial of Adrenalectomy Versus Observation for Subclinical Hypercortisolism|
- To determine whether adrenalectomy in patients diagnosed with subclinical hypercortisolism and a unilateral adrenal neoplasm results in normalization and/or improvement of metabolic complications. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- To determine the risk of primary adrenal malignancy in patients with subclinical hypercortisolism and adrenal mass less than 5 cm. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- To determine whether FDG PET/CT scan is diagnostic of subclinical hypercortisolism. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- To determine the optimal diagnostic test for subclinical hypercortisolism. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- To determine whether patients show an improvement in quality of life after adrenalectomy compared to medical therapy. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- To determine whether patients have an increased risk of deep venous thrombosis with subclinical hypercortisolism, regardless of treatment. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2013|
|Estimated Study Completion Date:||July 2019|
|Estimated Primary Completion Date:||October 2016 (Final data collection date for primary outcome measure)|
Surgical removal of one or both adrenal glands
Surgical removal of one or both adrenal glandsOther: Observation
Observation for 6 months prior to surgery
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT02001051
|Contact: Roxanne E Merkel||(301) firstname.lastname@example.org|
|Contact: Dhaval T Patel, M.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: Kaitlyn Chambers 301-402-4395 firstname.lastname@example.org|
|Contact: Roxanne Merkel (301) 402-4395 email@example.com|
|Principal Investigator:||Dhaval T Patel, M.D.||National Cancer Institute (NCI)|