NCT03364803 Collecting Information About Treatment Results for Patients With Cushing's Syndrome
| NCT ID | NCT03364803 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Memorial Sloan Kettering Cancer Center |
| Condition | Cushing's Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2017-11-28 |
| Primary Completion | 2026-11-28 |
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 300 participants in total. It began in 2017-11-28 with a primary completion date of 2026-11-28.
⚠ 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
The purpose of this study is to follow participants with Cushing's syndrome during the course of their routine care and to form a data registry to study long term participant outcomes.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03364803 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, studying Cushing's Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03364803 currently recruiting?
Yes, NCT03364803 is actively recruiting participants. Contact the research team at geere@mskcc.org for enrollment information.
Where is the NCT03364803 trial being conducted?
This trial is being conducted at Basking Ridge, United States, Middletown, United States, Montvale, United States, Commack, United States and 3 additional locations.
Who is sponsoring the NCT03364803 clinical trial?
NCT03364803 is sponsored by Memorial Sloan Kettering Cancer Center. The trial plans to enroll 300 participants.