Observing patients with Cushing's syndrome before and after treatment
Effects of CORtisol Excess and REmission in Cushing's Syndrome Over Time (CORRECT): A Prospective Non-interventional Cohort Study
This study looks at how Cushing's syndrome affects people's daily lives and health before and after they receive treatment to see if things get better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Aarhus Academic / other |
| Locations | 1 site (Aarhus, State) |
| Trial ID | NCT05521529 on ClinicalTrials.gov |
What this trial studies
This observational study aims to prospectively evaluate patients diagnosed with Cushing's syndrome, focusing on their physical function, quality of life, and circadian rhythms both before and after treatment. The study hypothesizes that Cushing's syndrome adversely affects health-related quality of life and physical functioning, and that these issues may improve following effective treatment. By analyzing changes in circadian rhythms at the whole body level and in specific tissues, the study seeks to provide insights into the broader impacts of the syndrome and its management.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old with a new diagnosis of Cushing's syndrome of endogenous origin.
Not a fit: Patients with active cancer, severe chronic diseases, or those unable to safely participate will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of how Cushing's syndrome affects patients' lives and inform better treatment strategies.
How similar studies have performed: While the specific approach of this study is observational, similar studies have shown success in understanding the impacts of chronic conditions on quality of life.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * New (≤ 2 months) diagnosis of Cushing's syndrome (CS) of endogenous etiology: * ACTH-dependent CS * ACTH-independent CS * Age \>18 years * Written informed consent Exclusion Criteria: * Active cancer * Iatrogenic or malignant cause of CS such as adrenocortical carcinoma * Chronic heart failure (New York Heart Association class IV) * Chronic kidney disease Chronic Kidney Disease stage ≥3 (eGFR \>30 ml/min) * Liver disease in the form of cirrhosis * Deemed unable to complete the study safely by investigator
Where this trial is running
Aarhus, State
- Department of Endocrinology and Internal Medicine — Aarhus, State, Denmark (Recruiting)
Study contacts
- Study coordinator: Simon Bøggild Hansen, MD
- Email: simhan@clin.au.dk
- Phone: 41111574
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.