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Questionnaires and Medical Record Review in Studying Treatment Outcomes in Patients with Cushing Syndrome
Trial Status: active
This study uses questionnaires and a medical record review to study treatment outcomes in patients with Cushing syndrome. Gathering health information through questionnaires and a medical record review over time may help doctors study long term patient outcomes and help improve future management of patients with Cushing syndrome.
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 principal investigator (PI), based on the below Endocrine Society and European Society of Endocrinology guidelines, the patient’s clinical presentation, and the PI’s judgement
* Diagnostic criteria for ACTH-dependent Cushing’s are according to the Endocrine Society guidelines and include: elevated 24-hour urinary free cortisol (UFC), normal or elevated plasma adrenocorticotropic hormone (ACTH), elevated midnight salivary cortisol levels, or classic dexamethasone suppression testing for CD (morning cortisol > 5 ug/dL after 1 mg overnight or classic 2-day low dose test) and a pituitary lesion on magnetic resonance imaging (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 CD (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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03364803.
I. To prospectively collect data on Cushing syndrome (CS) patients before and over time after surgical, medical, and/or radiation treatment.
OUTLINE: This is an observational study.
Patients' medical records are reviewed. Patients also complete 14 questionnaires over 50 minutes to 1 hour at pre-treatment (surgery, radiation therapy [RT], or medical therapy), and after treatment at approximately 6 months, 1-1.5 years, and then every 5 years thereafter. Questionnaires to be completed include the Cushing’s questionnaire, Cushing’s quality of life (QOL), Nottingham Health Profile (NHP), Hospital Anxiety and Depression Scale (HADS), Perceived Stress Scale, Barratt’s Impulsivity, Beck Depression Inventory, State-Trait Anxiety Inventory, Insomnia Severity Index, Brief Pain Inventory, State Food Craving, and Trait Food Craving questionnaires. Patients may also optionally undergo collection of blood samples.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationMemorial Sloan Kettering Cancer Center