RecruitingNot Applicable

Detecting Mild Autonomous Cortisol Secretion in Patients With Adrenal Incidentaloma

United States20 participantsStarted 2024-11-20

Plain-language summary

The aim of the proposed study is to estimate the incidence of Mild Autonomous Cortisol Secretion (MACS) in patients with Adrenal Incidentaloma (AI) and evaluate the available diagnostic tests to determine the most sensitive and specific combination of tests for assessing MACS from adrenal adenoma for prediction of the phenotype associated with cortisol excess. As well as following the patients for 4 years and see if anything changes.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Patients ages 18 years and older.
✓. Presence of adrenal incidentaloma by cat scan (CT) or magnetic resonance imaging (MRI) examination.
✓. 1-mg Dexamethasone suppression test cortisol ≤ 5 μg/dL with adequate dexamethasone level.

Exclusion criteria

✕. 1-mg Dexamethasone suppression test cortisol \> 5 μg/dL with adequate dexamethasone level. Patients who fail to suppress below this level will be considered to have Cushing's syndrome and will be referred for appropriate treatment.
✕. Current or recent (3 months) history of use of glucocorticoid medication (including joint injections of steroids).
✕. History of uncontrolled hypertension or history of hypertension with more than 2 medications.
✕. History of uncontrolled type 2 Diabetes Mellitus or history of diabetes mellitus with A1c\>7.5.
✕. Known History of osteoporosis
✕. Documented Clinical Cushing's disease.
✕. Clinical suspicion of adrenal carcinoma.
✕. History of alcohol abuse/dependence.

What they're measuring

Evaluate best diagnostic test(s)

Timeframe: 5 years

Trial details

NCT IDNCT06344143

SponsorThe Cleveland Clinic

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2029-12-01

Contact for this trial

Kimberly Jenkins

216-445-4791 jenkink@ccf.org

View on ClinicalTrials.gov More Mild Autonomous Cortisol Secretion (MACS) trials