RECRUITING

Detecting Mild Autonomous Cortisol Secretion in Patients with Adrenal Incidentaloma

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Conditions

Mild Autonomous Cortisol Secretion (MACS)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Detecting Mild Autonomous Cortisol Secretion in Patients with Adrenal Incidentaloma

Quick Facts

Study Start:2024-11-20
Study Completion:2030-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06344143

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patients ages 18 years and older.
  2. 2. Presence of adrenal incidentaloma by cat scan (CT) or magnetic resonance imaging (MRI) examination.
  3. 3. 1-mg Dexamethasone suppression test cortisol ≤ 5 μg/dL with adequate dexamethasone level.
  1. 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. 2. Current or recent (3 months) history of use of glucocorticoid medication (including joint injections of steroids).
  3. 3. History of uncontrolled hypertension or history of hypertension with more than 2 medications.
  4. 4. History of uncontrolled type 2 Diabetes Mellitus or history of diabetes mellitus with A1c\>7.5.
  5. 5. Known History of osteoporosis
  6. 6. Documented Clinical Cushing's disease.
  7. 7. Clinical suspicion of adrenal carcinoma.
  8. 8. History of alcohol abuse/dependence.
  9. 9. History of cirrhosis of liver.
  10. 10. History of hepatitis B or C infection regardless of treatment.
  11. 11. History of type 1 diabetes.
  12. 12. History of hemochromatosis.
  13. 13. History of autoimmune hepatitis.
  14. 14. History of Wilson's disease.

Contacts and Locations

Study Contact

Kimberly Jenkins
CONTACT
216-445-4791
jenkink@ccf.org
Andrea Parianos
CONTACT
216 210-7832
debsa@ccf.org

Principal Investigator

Ricardo Correa, MD
PRINCIPAL_INVESTIGATOR
The Cleveland Clinic

Study Locations (Sites)

The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States

Collaborators and Investigators

Sponsor: The Cleveland Clinic

  • Ricardo Correa, MD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-20
Study Completion Date2030-12-31

Study Record Updates

Study Start Date2024-11-20
Study Completion Date2030-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Mild Autonomous Cortisol Secretion (MACS)