Treatment Outcomes for Patients With Cushing's Syndrome: a Prospective Data Collection Study

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 14
Healthy Volunteers: f
View:

• 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.

Locations
United States
New Jersey
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
RECRUITING
Basking Ridge
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
RECRUITING
Middletown
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
RECRUITING
Montvale
New York
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activity)
RECRUITING
Commack
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
RECRUITING
Harrison
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
RECRUITING
Uniondale
Contact Information
Primary
Eliza Geer, MD
geere@mskcc.org
646-888-2627
Backup
Marc Cohen, MD
cohenm2@mskcc.org
212-639-3769
Time Frame
Start Date: 2017-11-28
Estimated Completion Date: 2025-11-28
Participants
Target number of participants: 200
Treatments
Participants with Cushing's Syndrome
Sponsors
Leads: Memorial Sloan Kettering Cancer Center

This content was sourced from clinicaltrials.gov