Collecting information on treatment results for patients with Cushing's syndrome
Treatment Outcomes for Patients With Cushing's Syndrome: a Prospective Data Collection Study
Memorial Sloan Kettering Cancer Center · NCT03364803
This study is collecting information from people with Cushing's syndrome during their regular treatment to see how the condition affects their quality of life and mental health over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 14 Years and up |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center (other) |
| Locations | 7 sites (Basking Ridge, New Jersey and 6 other locations) |
| Trial ID | NCT03364803 on ClinicalTrials.gov |
What this trial studies
This observational study aims to follow participants diagnosed with Cushing's syndrome throughout their routine care, creating a comprehensive data registry to analyze long-term outcomes. Participants will be assessed using various quality of life and psychological questionnaires, including the Cushing's QoL, Nottingham Health Profile, and Hospital Anxiety and Depression Scale. The study seeks to gather valuable information that can enhance understanding of the condition and improve patient care.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 14 or older with active or treated overt Cushing's syndrome or mild adrenal Cushing's syndrome.
Not a fit: Patients without a confirmed diagnosis of Cushing's syndrome or those under the age of 14 may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights that lead to improved management and treatment strategies for patients with Cushing's syndrome.
How similar studies have performed: Other studies focusing on patient registries for chronic conditions have shown success in improving treatment outcomes and understanding disease progression.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 14 or older * Active or treated overt Cushing's (due to pituitary, ectopic, or adrenal tumor), mild adrenal Cushing's syndrome (MACS), or a silent corticotroph tumor * The diagnosis of CS or MACS will be made by the PI, based on the below Endocrine Society guidelines, the patient's clinical presentation, and the PI's judgment. * Diagnostic criteria for ACTH-dependent Cushing's are according to the Endocrine Society and European Society of Endocrinology guidelines and include: Elevated 24-hour urinary free cortisol (UFC), normal or elevated plasma ACTH, elevated midnight salivary cortisol levels, or classic dexamethasone suppression testing for CD (morning cortisol \> 5 ug/dL after 1 mg overnight of classic 2-day low dose test) and a pituitary lesion on MRI (in the case of pituitary Cushing's). If patient does not have any of these results, pathology of ACTH tumor may confirm presence of disease. * Diagnostic criterion for MACS is according to the European Society of Endocrinology guidelines: Classic dexamethasone suppression testing for CS (morning cortisol \>1.8 µg/dL after 1 mg overnight) and the presence of an adrenal adenoma. * Silent corticotroph tumors will be defined by surgical pathology demonstrating positivity for ACTH, in the absence of clinical and biochemical features of Cushing's syndrome. * In lieu of MRI, surgical, or laboratory reports, physician's assessment note including mention of results will also be used as source for eligibility purposes. Exclusion Criteria: * Patients with a diagnosis of iatrogenic Cushing's.
Where this trial is running
Basking Ridge, New Jersey and 6 other locations
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey, United States (RECRUITING)
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown, New Jersey, United States (RECRUITING)
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale, New Jersey, United States (RECRUITING)
- Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activity) — Commack, New York, United States (RECRUITING)
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison, New York, United States (RECRUITING)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (RECRUITING)
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale, New York, United States (RECRUITING)
Study contacts
- Study coordinator: Eliza Geer, MD
- Email: geere@mskcc.org
- Phone: 646-888-2627
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.
Conditions: Cushing's Disease, Cushing Syndrome, Cushing Disease, 17-592, Memorial Sloan Kettering Cancer Center