NCT03364803Recruiting
Collecting Information About Treatment Results for Patients With Cushing's Syndrome
Memorial Sloan Kettering Cancer Center
Start Date
11/28/2017
Completion Date
11/28/2026
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
Age Range: 14 years to No maximum
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.
Interventions
OTHER
Cushing's QoL (Quality of Life Questionnaire)
OTHER
Nottingham Health Profile (NHP)
OTHER
Hospital Anxiety and Depression Scale (HADS)
OTHER
Perceived Stress Scale (PSS)
OTHER
Barratt's Impulsivity Scale (BIS)
OTHER
Beck Depression Inventory (BDI)
OTHER
State-Trait Anxiety Inventory (STAI)
OTHER
State Food Craving Questionnaire-State (FCQ-S)
OTHER
Trait Food Craving Questionnaire-Trait (FCQ-T)
OTHER
Visual Analogue Scale (VAS)
OTHER
Sensitivity to Reinforcement of Addictive and other Primary Rewards (STRAP-R) food variant
Conditions
Cushing's DiseaseCushing SyndromeCushing Disease
Locations
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey 07920
United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey 07748
United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey 07645
United States
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activity)
Commack, New York 11725
United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York 10604
United States
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York 11553
United States