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NCT03364803 | RECRUITING | Cushing's Disease

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

Memorial Sloan Kettering Cancer Center

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.

Condition or disease

Cushing's Disease

Cushing Syndrome

Cushing Disease

Intervention/treatment

Cushing's QoL (Quality of Life Questionnaire)

Nottingham Health Profile (NHP)

Hospital Anxiety and Depression Scale (HADS)

Perceived Stress Scale (PSS)

Barratt's Impulsivity Scale (BIS)

Beck Depression Inventory (BDI)

State-Trait Anxiety Inventory (STAI)

State Food Craving Questionnaire-State (FCQ-S)

Trait Food Craving Questionnaire-Trait (FCQ-T)

Visual Analogue Scale (VAS)

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

Study Type : OBSERVATIONAL
Estimated Enrollment : 300 participants
Official Title : Treatment Outcomes for Patients With Cushing's Syndrome: a Prospective Data Collection Study
Actual Study Start Date : 2017-11-28
Estimated Primary Completion Date : 2026-11-28
Estimated Study Completion Date : 2026-11-28

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 14 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Collecting Information About Treatment Results for Patients With Cushing's Syndrome

Location Details

NCT03364803

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, New Jersey

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States, 07920

RECRUITING

United States, New Jersey

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States, 07748

RECRUITING

United States, New Jersey

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States, 07645

RECRUITING

United States, New York

Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activity)

Commack, New York, United States, 11725

RECRUITING

United States, New York

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States, 10604

RECRUITING

United States, New York

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

RECRUITING

United States, New York

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, United States, 11553