Adrenal Incidentaloma Clinical Trial
Official title:
Natural History of Benign Nonfunctioning Adrenal Tumors: 10 Year Follow-up Results
NCT number | NCT04616703 |
Other study ID # | 00000 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 1, 2019 |
Est. completion date | December 1, 2020 |
The data on long term natural history of benign nonfunctioning adrenal tumors (NFATs) are lacking. The aim is to identify clinical characteristics associated with tumor growth and progression to mild autonomous cortisol excess over time.
Status | Recruiting |
Enrollment | 65 |
Est. completion date | December 1, 2020 |
Est. primary completion date | November 15, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients hospitalized because of NFAI between 2005-2012 at the Department of Endocrinology, Diabetes and Metabolic Disease, University Medical Center Ljubljana, Ljubljana, Slovenia. Exclusion Criteria: - age below 18 years - relatives reported that patient died in the time since hospitalization - patient did not want a follow up - patient did not attend follow up appointment - patient underwent adrenalectomy - misdiagnosis / missing main information in hospitalization record |
Country | Name | City | State |
---|---|---|---|
Slovenia | Department of Internal Medicine, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia | Ljubljana |
Lead Sponsor | Collaborator |
---|---|
University Medical Centre Ljubljana | University of Ljubljana, Faculty of Medicine, University Rehabilitation Institute, Republic of Slovenia |
Slovenia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Natural History of NFAT - horomnal activity | To determine if and in how many pateints NFAI progressed to MACE.
NFAI: when cortisol after 1 mg overnight dexamethasone (ODST) suppression test is < 50 nmol/l and no typical clinical signs of Cushing's syndrome are present. Pheochromocytoma and primary aldosteronism will be excluded. MACE: when cortisol after 1 mg overnight dexamethasone (ODST) suppression test is > 50 nmol/l. |
10 years | |
Primary | Natural History of NFAT - growth | To determine the change in size of NFAI on the CT scan (mm). | 10 years | |
Primary | Natural History of NFAT - BMI | To determine the change in BMI and its correlation with outcome 1 and 2.
Weight and height will be combined to report BMI in kg/m^2. |
10 years |
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