Collecting Information About Treatment Results for Patients With Cushing's Syndrome

Memorial Sloan Kettering Cancer Center (MSK)

Status: Enrolling

Conditions: Cushing Disease; Cushing's Disease; Cushing Syndrome

Treatments: Other: Hospital Anxiety and Depression Scale (HADS); Other: Nottingham Health Profile (NHP); Other: Visual Analogue Scale (VAS); Other: Cushing's QoL (Quality of Life Questionnaire); Other: Trait Food Craving Questionnaire-Trait (FCQ-T); Other: State-Trait Anxiety Inventory (STAI); Other: Perceived Stress Scale (PSS); Other: State Food Craving Questionnaire-State (FCQ-S); Other: Beck Depression Inventory (BDI); Other: Barratt's Impulsivity Scale (BIS); Other: Sensitivity to Reinforcement of Addictive and other Primary Rewards (STRAP-R) food variant

Study type: Observational

Funder types: Other

Identifiers

NCT03364803

17-592

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 14+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

300 participants in 1 patient group

Participants with Cushing's Syndrome

Treatment:

Other: Sensitivity to Reinforcement of Addictive and other Primary Rewards (STRAP-R) food variant

Other: Barratt's Impulsivity Scale (BIS)

Other: State Food Craving Questionnaire-State (FCQ-S)

Other: Beck Depression Inventory (BDI)

Other: Perceived Stress Scale (PSS)

Other: State-Trait Anxiety Inventory (STAI)

Other: Trait Food Craving Questionnaire-Trait (FCQ-T)

Other: Cushing's QoL (Quality of Life Questionnaire)

Other: Visual Analogue Scale (VAS)

Other: Nottingham Health Profile (NHP)

Other: Hospital Anxiety and Depression Scale (HADS)