Adrenal Incidentaloma Clinical Trial
Official title:
Morbidity and Mortality in Patients With Adrenal Incidentalomas With and Without Autonomous Cortisol Secretion
NCT number | NCT03919734 |
Other study ID # | 1 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 15, 2015 |
Est. completion date | January 3, 2020 |
Verified date | March 2021 |
Source | Region Skane |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Benign enlargements of the adrenal glands (adrenal adenomas) are frequent in adults. In the general population these adenomas are rare in subjects below 40 years of age but at the age of 60 and 80 years the prevalence is 6 and 8-10 % respectively. Since these adenomas do not causes obvious symptoms they are almost exclusively found incidentally in patients examined radiologically for other reasons than suspected adrenal disease. These enlargements are thus termed adrenal incidentalomas (AI). AI may secrete cortisol and more than 25 percent of patients with an AI have increased cortisol levels called autonomous cortisol secretion (ACS). Such increased secretion of cortisol may cause metabolic complications such as hypertension, high cholesterol, diabetes and cardiovascular disease. Studies have shown that ACS may cause increased mortality. These studies are however small and have not adequately taking other conditions into account which most likely influences the result. The investigators hypothesis is that ACS is linked to increased mortality as the previous studies have shown. The aim is to perform a larger study on patients with adrenal incidentalomas, both with and without ACS, and compare the mortality rates with a control group matched for age and sex. This study may more precisely describe the cardiovascular risk for ACS and define the risk at different levels of ACS.
Status | Completed |
Enrollment | 4596 |
Est. completion date | January 3, 2020 |
Est. primary completion date | January 3, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Patients with adrenal incidentalomas examined at Skane University Hospital and Helsingborg Hospital during the period from January 1, 2005 to September 15, 2015. Exclusion Criteria: 1. Size of incidentaloma below 1 cm 2. Malignant disease with metastases, 3. Incidentaloma not an adenoma but for example malignancy, myelolipoma and bleedings 4. Pheochromocytomas 5. Primary aldosteronism 6. Continuous treatment with systemic glucocorticoid under the last 3 months. 7. Cushing Syndrome 8. Medication affecting dexamethasone metabolism. 9. Treatment with systemic estrogen |
Country | Name | City | State |
---|---|---|---|
Sweden | Dept. of Endocrinology, Skåne University Hospital | Lund | Skåne |
Lead Sponsor | Collaborator |
---|---|
Region Skane |
Sweden,
Debono M, Bradburn M, Bull M, Harrison B, Ross RJ, Newell-Price J. Cortisol as a marker for increased mortality in patients with incidental adrenocortical adenomas. J Clin Endocrinol Metab. 2014 Dec;99(12):4462-70. doi: 10.1210/jc.2014-3007. — View Citation
Di Dalmazi G, Vicennati V, Garelli S, Casadio E, Rinaldi E, Giampalma E, Mosconi C, Golfieri R, Paccapelo A, Pagotto U, Pasquali R. Cardiovascular events and mortality in patients with adrenal incidentalomas that are either non-secreting or associated with intermediate phenotype or subclinical Cushing's syndrome: a 15-year retrospective study. Lancet Diabetes Endocrinol. 2014 May;2(5):396-405. doi: 10.1016/S2213-8587(13)70211-0. Epub 2014 Jan 29. — View Citation
Fassnacht M, Arlt W, Bancos I, Dralle H, Newell-Price J, Sahdev A, Tabarin A, Terzolo M, Tsagarakis S, Dekkers OM. Management of adrenal incidentalomas: European Society of Endocrinology Clinical Practice Guideline in collaboration with the European Network for the Study of Adrenal Tumors. Eur J Endocrinol. 2016 Aug;175(2):G1-G34. doi: 10.1530/EJE-16-0467. — View Citation
Olsen H, Kjellbom A, Löndahl M, Lindgren O. Suppressed ACTH Is Frequently Unrelated to Autonomous Cortisol Secretion in Patients With Adrenal Incidentalomas. J Clin Endocrinol Metab. 2019 Feb 1;104(2):506-512. doi: 10.1210/jc.2018-01029. — View Citation
Patrova J, Kjellman M, Wahrenberg H, Falhammar H. Increased mortality in patients with adrenal incidentalomas and autonomous cortisol secretion: a 13-year retrospective study from one center. Endocrine. 2017 Nov;58(2):267-275. doi: 10.1007/s12020-017-1400-8. Epub 2017 Sep 8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients deceased, both totally and divided into three specified diagnose groups (cardiovascular disease, infections and cancer). | The cause of death is defined by the ICD-10 code reported by The National Board of Health and Welfare. | From date of enrollment until December 31, 2018. | |
Secondary | A composite of cardiovascular death, nonfatal myocardial infarction (excluding silent myocardial infarction), nonfatal stroke, hospitalization for heart failure and revascularization (CABG and PCI). The endpoints will also be calculated separately. | The diagnoses is defined by the ICD-10 code and Swedish classification of healthcare interventions (KVÅ-codes FNA-FNG) both reported by The National Board of Health and Welfare | From date of enrollment until December 31, 2017. |
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