An observational study in Adrenal Incidentaloma and Cortisol Overproduction, sponsored by Region Skane. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-26.
Sponsored by Region Skane · Observational
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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.
Patients with adrenal adenomas may have autonomous cortisol secretion (ACS) that has been linked to hypertension, diabetes, dyslipidemia and cardiovascular disease. Patients with ACS also have been found to have increased mortality. In two studies the excess mortality was caused by cardiovascular disease and in one study by cancer.
ACS is diagnosed by increased cortisol (≥50 nmol/l) following 1-mg dexamethasone suppression (DST) often in combination with another confirmatory test such as low ACTH, increased urinary cortisol, increased midnight salivary cortisol or a dexamethasone suppression test with a higher dexamethasone dose. Cortisol secretion from an AI has been considered exclusively autonomous but the investigators have recently shown that a large group of patients with normal results on DST have low ACTH indicating that another factor than ACS may suppress the HPA-axis. The hypothesis is that these patients have an increased sensitivity to ACTH, which results in lower ACTH levels. It has however not been studied whether the increased sensitivity to ACTH is linked to increased cardiovascular morbidity and mortality.
Patient data is collected from the patient cards and radiology images. Patients are included according to the eligibility criteria. The patients will be separated in the following groups:
Three age and gender matched subjects from the general population for every patient will serve as a controls.
Outcome data on patients and controls is received from The National Board of Health and Welfare. The control group is achieved from SCB, Sweden (Statistics Sweden). The following outcome data will be collected: Data on mortality, cause of mortality and inpatient and outpatient cardiovascular diagnoses. The study design reduces the risk for bias between the clinical endpoints and the patient's cortisol and ACTH levels. The patient cohorts will be finally defined before the investigators receive the clinical endpoints from The National Board of Health and Welfare.
Statistical analysis: The prevalence of the outcome data in the groups of patients will be compared. The investigators will adjusted for differences between the groups in sex, age, smoking, impaired renal function, and existing cardiovascular disease.
The following variables will be examined in relation to the outcome data: Cortisol following dexamethasone (≥50 nmol/l, ≥83 nmol/l and ≥138 nmol/l), low basal ACTH (\<2.0 pmol/l), DHEAS, the size of the AI and bilateral versus unilateral AI.
Study Status: We anticipate to receive the outcome data from The National Board of Health and Welfare in October 2019. The study has thus been slightly delayed. Data on morbidity will only be available until December 31, 2017 due to a delay in reporting to The National Board of Health and Welfare. The secondary outcome measure has been changed to a composite of cardiovascular endpoints.
27 studies on the registry are indexed under Adrenal incidentaloma; 12 are open to participants now.
This study's enrollment of 4,596 is above the median of 300 across 18 observational studies indexed under Adrenal incidentaloma.
Browse Adrenal incidentaloma studies →Region Skane is the lead sponsor of 386 studies on the registry; 122 are open to participants now.
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Patients examined at the Endocrine outpatient ambulatory first time for adrenal incidentalomas during the period from January 1, 2005 to September 15, 2015.
A Group of Age and sex matched controls developed by SCB.
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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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with adrenal incidentalomas and cortisol following overnight 1-mg dexamethasone suppression equal to or above 50 nmol/l. The patients should not have clinical signs of Cushing Syndrome, such as catabolic skin and muscle changes.
Patients with adrenal incidentalomas and cortisol following overnight 1-mg dexamethasone suppression below 50 nmol/l.
Patients treated with inhalation steroids with and without ACS/possible ACS but not operated with adrenalectomy.
Patients with unilateral AI operated with adrenalectomy
A Group of Controls matched for sex and age, achieved by the government agency "Statistics Sweden" (SCB).
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.
Time frame: From date of enrollment until December 31, 2018.
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
Time frame: From date of enrollment until December 31, 2017.
Plan to share: No
Ran from Sep 2015 to primary completion in Jan 2020, 51 months.
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This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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