NCT04543253 Recovery From Cushing Syndrome and Mild Autonomous Cortisol Secretion (MACS)
| NCT ID | NCT04543253 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mayo Clinic |
| Condition | Cushing Syndrome |
| Study Type | OBSERVATIONAL |
| Enrollment | 700 participants |
| Start Date | 2019-07-25 |
| Primary Completion | 2030-12 |
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 700 participants in total. It began in 2019-07-25 with a primary completion date of 2030-12.
⚠ 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
Cushing syndrome (CS) is an endocrine disorder caused by chronic exposure to glucocorticoid (GC) excess. Endogenous CS has an estimated incidence of 0.2 to 5.0 cases per million per year and prevalence of 39 to 79 cases per million in various populations. CS usually affects young women, with a median age at diagnosis of 41.4 with a female-to-male ratio of 3:1. Following a curative surgery for CS, patients develop adrenal insufficiency and require GC replacement postoperatively until the hypothalamic-pituitary-adrenal (HPA) axis recovery occurs. Factors, such as age, gender, BMI, subtypes of CS, duration of symptoms, clinical and biochemical severity and postoperative GC dose have been reported to affect the HPA recovery in small retrospective studies. Glucocorticoid withdrawal syndrome (GWS) is a withdrawal reaction due to decrease in supraphysiological GC concentrations, which occurs after a successful surgery of CS. Glucocorticoid withdrawal syndrome (GWS) is under-recognized entity in patients undergoing curative surgery for endogenous Cushing syndrome. In this study we aim to determine pre- and post-surgical predictors of the duration and severity of glucocorticoid withdrawal in patients undergoing a curative surgery for cortisol excess and assess the effect of MUSE intervention on GWS severity in patients undergoing curative surgery for CS as compared to standard of care.
Eligibility Criteria
Inclusion Criteria: 1. age 18 and above, 2. new diagnosis of CS of any of the three subtypes (pituitary, adrenal or ectopic CS), and MACS, 3. planning for a curative surgery 4. ability to provide informed consent. Exclusion Criteria: 1. systemic supraphysiological GC for any reason within 1 month of enrollment, for more than 2 weeks, 2. inability to provide informed consent
Contact & Investigator
Irina Bancos, MD, MS
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT04543253 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cushing Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04543253 currently recruiting?
Yes, NCT04543253 is actively recruiting participants. Contact the research team at fell.vanessa@mayo.edu for enrollment information.
Where is the NCT04543253 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT04543253 clinical trial?
NCT04543253 is sponsored by Mayo Clinic. The principal investigator is Irina Bancos, MD, MS at Mayo Clinic. The trial plans to enroll 700 participants.