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NCT04543253 · ClinicalTrials.gov registry record
Recovery From Cushing Syndrome and Mild Autonomous Cortisol Secretion (MACS)
A clinical trial of Cushing Syndrome, sponsored by Mayo Clinic.
- Recruiting
- Registry status
- 700
- Enrollment target
- 1
- Study location
NCT04543253 is a study of Cushing Syndrome that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 700 participants, above the 103-participant average among 9 other Cushing Syndrome trials with a reported enrollment target (580% higher). The trial reports 1 study location across 1 state.
The verdict
NCT04543253, a study of Cushing Syndrome, is actively recruiting participants, sponsored by Mayo Clinic.
- RECRUITING
- Registry status
- 700 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- OTHER MUSE biofeedback
Study Locations (1)
Minnesota
- Mayo Clinic - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 700 participants |
| Start Date | 2019-07-25 |
| Est. Completion | 2030-12 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04543253
The ClinicalTrials.gov registry entry for NCT04543253 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 700 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 103-participant average among 9 other Cushing Syndrome trials with a reported enrollment target (580% higher). The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Cushing Syndrome appearing as the primary indexed condition, and to 1 intervention - of which MUSE biofeedback is the first listed.
NCT04543253 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.
Frequently Asked Questions
What is clinical trial NCT04543253 about?
NCT04543253 is a clinical study titled "Recovery From Cushing Syndrome and Mild Autonomous Cortisol Secretion (MACS)". 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 media...
What is the current status of trial NCT04543253?
This trial is currently recruiting. The enrollment target is 700 participants. The study started on 2019-07-25. Estimated completion is 2030-12.
What conditions does trial NCT04543253 study?
This clinical trial studies the following conditions: Cushing Syndrome.
What interventions are being tested in trial NCT04543253?
The interventions under investigation include: MUSE biofeedback (OTHER).
Who is sponsoring clinical trial NCT04543253?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04543253 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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