NCT06344143 Detecting Mild Autonomous Cortisol Secretion in Patients With Adrenal Incidentaloma
| NCT ID | NCT06344143 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Cleveland Clinic |
| Condition | Mild Autonomous Cortisol Secretion (MACS) |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-11-20 |
| Primary Completion | 2029-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2024-11-20 with a primary completion date of 2029-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1. Patients ages 18 years and older. 2. Presence of adrenal incidentaloma by cat scan (CT) or magnetic resonance imaging (MRI) examination. 3. 1-mg Dexamethasone suppression test cortisol ≤ 5 μg/dL with adequate dexamethasone level. Exclusion Criteria: 1. 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. 2. Current or recent (3 months) history of use of glucocorticoid medication (including joint injections of steroids). 3. History of uncontrolled hypertension or history of hypertension with more than 2 medications. 4. History of uncontrolled type 2 Diabetes Mellitus or history of diabetes mellitus with A1c\>7.5. 5. Known History of osteoporosis 6. Documented Clinical Cushing's disease. 7. Clinical suspicion of adrenal carcinoma. 8. History of alcohol abuse/dependence. 9. History of cirrhosis of liver. 10. History of hepatitis B or C infection regardless of treatment. 11. History of type 1 diabetes. 12. History of hemochromatosis. 13. History of autoimmune hepatitis. 14. History of Wilson's disease.
Contact & Investigator
Ricardo Correa, MD
PRINCIPAL INVESTIGATOR
The Cleveland Clinic
Frequently Asked Questions
Who can join the NCT06344143 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Mild Autonomous Cortisol Secretion (MACS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06344143 currently recruiting?
Yes, NCT06344143 is actively recruiting participants. Contact the research team at jenkink@ccf.org for enrollment information.
Where is the NCT06344143 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT06344143 clinical trial?
NCT06344143 is sponsored by The Cleveland Clinic. The principal investigator is Ricardo Correa, MD at The Cleveland Clinic. The trial plans to enroll 20 participants.