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

Recruiting

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

• Registration Number: NCT03364803
• Lead 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-28
• Study First Submitted: 2017-12-01
• Study First Submitted QC: 2017-12-01
• Study First Posted: 2017-12-07
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-26
• Primary Completion: 2025-11-28
• Study Completion: 2025-11-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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. 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).

• For pituitary Cushing's patients, if the patient demonstrates non-classic testing or no pituitary lesion is seen on MRI then petrosal sinus sampling or positive surgical pathology will be used to confirm pituitary source of Cushing's. Clinical or biochemical remission after surgery will also confirm pituitary source.

• Ectopic Cushing's will be confirmed by petrosal sinus sampling and appropriate imaging tests, or positive surgical pathology.

• Adrenal Cushing's will be confirmed by a suppressed plasma ACTH value and identification of an adrenal lesion on CT or MRI, or positive surgical pathology.

• 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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Collection of data on Cushing's Syndrome participants before and over time after surgical, medication, and/or radiation therapy.	up to 10 years after treatment

Trial Locations

Locations (7)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities); 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activity); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities); 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities); 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities); 🇺🇸 Montvale, New Jersey, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities); 🇺🇸 Uniondale, New York, United States