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

  • STATUS
    Recruiting
  • End date
    Nov 28, 2024
  • participants needed
    200
  • sponsor
    Memorial Sloan Kettering Cancer Center
Updated on 26 March 2022
remission
pituitary
depression
anxiety
dexamethasone
laboratory reports
adrenal neoplasm
ACTH
corticotropin
cushing's syndrome
free cortisol
urinary free cortisol
inferior petrosal sinus sampling

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.

Details
Condition Cushing's Disease, Cushing Syndrome, Cushing Disease
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
Clinical Study IdentifierNCT03364803
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on26 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 14 or older
Active or treated Cushing's (due to pituitary, ectopic, or adrenal tumor)
The diagnosis of CS 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 pituitary CD are according to the Endocrine Society
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
For pituitary 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
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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