Clinical trial NCT03364803: Collecting Information About Treatment Results for Patients With Cushing's Syndrome
Official title: Treatment Outcomes for Patients With Cushing's Syndrome: a Prospective Data Collection Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cushing's Disease
Cushing Syndrome
Cushing Disease
Keywords: Cushing Syndrome
Cushing's Disease
Cushing Disease
17-592
Memorial Sloan Kettering Cancer Center
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2017-12-07
Enrollment: 200
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team at Memorial Sloan-Kettering Cancer Center (MSKCC). If the investigator is a member of the treatment team, s/he will screen their patient's medical records for suitable research study participants and discuss the study and their potential for enrolling in the research study. Potential subjects contacted by their treating physician will be referred to the investigator/research staff of the study.

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.


Eligibility 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. 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.

Primary outcomes:
measure: Collection of data on Cushing's Syndrome participants before and over time after surgical, medication, and/or radiation therapy.
timeFrame: up to 10 years after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Limited Protocol Activities)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activity)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Limited Protocol Activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (Limited Protocol Activities)
state: New York
Study officials:
References: