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.
|Subclinical Hypercortisolism Cushing Syndrome Adrenal Neoplasm||Procedure: Adrenalectomy Other: Observation||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Randomized Control Trial of Adrenalectomy Versus Observation for Subclinical Hypercortisolism|
- Proportion of patients that have normalization and/or improvementof metabolic complications after adrenalectomy. [ Time Frame: 6 months ]
- Proportion of patients who are found to have adrenal cancer afteradrenalectomy. [ Time Frame: 6 months ]
- Proportion of patients who were diagnosed with subclinicalhypercortisolism by FDG PET/CT scan [ Time Frame: 6 months ]
- To determine the optimal diagnostic test for subclinical hypercortisolism. [ Time Frame: 6 months ]
- Proportion of patients that have improvement in quality of life afteradrenalectomy compared to medical therapy. [ Time Frame: 6 months ]
- Proportion of patients that developed deep venous thrombosiswith subclinical hypercortisolism [ Time Frame: 6 months ]
- Correlation between dermal thickness and diagnostic of subclinical hypercortisolism [ Time Frame: 6 months ]
|Study Start Date:||November 19, 2013|
|Estimated Study Completion Date:||July 1, 2020|
|Estimated Primary Completion Date:||July 1, 2019 (Final data collection date for primary outcome measure)|
Surgery to remove tumor when enrolled in the protocol.
delayed operative arm
Observation for 6 months prior to surgery
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT02001051
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Dhaval T Patel, M.D.||National Cancer Institute (NCI)|