Detecting Mild Autonomous Cortisol Secretion in Patients With Adrenal Incidentaloma

NCT06344143 | Recruiting

• 1 other identifier: 24-324
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mild Autonomous Cortisol Secretion (MACS)

Outcome Measures

Primary Outcomes (1)

• Evaluate best diagnostic test(s)

  To evaluate and determine the most sensitive and specific combination of tests for assessing mild autonomous cortisol secreting (MACS) from adrenal adenoma for prediction of the phenotype associated with cortisol excess. Study team will measure cortisol in serum, cortisol in saliva, cortisol in urine, vasopressin stimulation test, 1 mg dexamethasone stimulation test (DST) and a 2 mg DST, Adrenocorticotropic Hormone test (ACTH) and (dehydroepiandrosterone sulfate test) DHEAS. With this, a diagnosis of MACS can be determined. To determine the sensitivity of each the area under the curve (AUC) will be compared with the standard test which is 1 mg DST.

  5 years

Interventions

Various labs and imaging tests DIAGNOSTIC_TEST

Dexamethasone Suppression Test, Adrenocorticotropic Hormone (ACTH), Salivary Cortisol Levels, Vasopressin Stimulation test, Fasting Glucose, Fasting Insulin, Complete Metabolic Panel (CMP), Gamma-glutamyl transferase (GGT), Sex Hormone Binding Globulin, Cat scan of abdomen/Pelvis, Whole body dual energy x-ray absorptiometry (DXA) scan, Ultrasound Fibroscan Transient Elastography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited from Endocrinology patients who have previously undergone dexamethasone suppression testing for Adrenal Incidentaloma (AI) or have been diagnosed with AI and have been seen at the Endocrinology and Metabolism institute (EMI). They will be identified from review the laboratory database and clinical records. All subjects with a dexamethasone suppression test \<5 micrograms/dL will be invited to participate in the study.

You may qualify if:

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

You may not qualify if:

• 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.
• History of cirrhosis of liver.
• History of hepatitis B or C infection regardless of treatment.
• History of type 1 diabetes.
• History of hemochromatosis.
• History of autoimmune hepatitis.
• History of Wilson's disease.

Sponsors & Collaborators

• The Cleveland Clinic: lead
• RECORDATI GROUP: collaborator

Study Sites (1)

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

RECRUITING

Study Officials

• Ricardo Correa, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kimberly Jenkins

CONTACT

216-445-4791; jenkink@ccf.org

Andrea Parianos

CONTACT

216 210-7832; debsa@ccf.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2024
• First Posted: April 3, 2024
• Study Start: November 20, 2024
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)