- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03364803
Collecting Information About Treatment Results for Patients With Cushing's Syndrome
Treatment Outcomes for Patients With Cushing's Syndrome: a Prospective Data Collection Study
Study Overview
Status
Conditions
Intervention / Treatment
- 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
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Eliza Geer, MD
- Phone Number: 646-888-2627
- Email: geere@mskcc.org
Study Contact Backup
- Name: Marc Cohen, MD
- Phone Number: 212-639-3769
- Email: cohenm2@mskcc.org
Study Locations
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New Jersey
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Basking Ridge, New Jersey, United States, 07920
- Recruiting
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
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Contact:
- Eliza Geer, MD
- Phone Number: 646-888-2627
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Middletown, New Jersey, United States, 07748
- Recruiting
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
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Contact:
- Eliza Geer, MD
- Phone Number: 646-888-2627
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Montvale, New Jersey, United States, 07645
- Recruiting
- Memorial Sloan Kettering Bergen (Limited Protocol Activities)
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Contact:
- Eliza Geer, MD
- Phone Number: 646-888-2627
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New York
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Commack, New York, United States, 11725
- Recruiting
- Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activity)
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Contact:
- Eliza Geer, MD
- Phone Number: 646-888-2627
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Harrison, New York, United States, 10604
- Recruiting
- Memorial Sloan Kettering Westchester (Limited Protocol Activities)
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Contact:
- Eliza Geer, MD
- Phone Number: 646-888-2627
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New York, New York, United States, 10065
- Recruiting
- Memorial Sloan Kettering Cancer Center
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Contact:
- Eliza Geer, MD
- Phone Number: 646-888-2627
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Uniondale, New York, United States, 11553
- Recruiting
- Memorial Sloan Kettering Nassau (Limited Protocol Activities)
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Contact:
- Eliza Geer, MD
- Phone Number: 646-888-2627
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Participants with Cushing's Syndrome
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Cushing's QoL is a validated disease specific questionnaire consisting of 12 questions on a five-point Likert scale ranging from always to never.
The total score ranges from 12 to 60, with a lower score indicating a greater negative impact on health related QoL.
This is converted to a 0-100 scale, 0 indicating the worst and 100 indicating the best QoL
NHP is used in patients to assess general health and quality of life.
This assessment consists of 38 yes/no questions that are subdivided into six scales assessing impairments: pain (eight items), energy level (three items), sleep (five items), emotional reactions (nine items), social isolation (five items) and physical mobility (eight items).
A higher score indicates more impairment
HADS consists of 14 items pertaining to anxiety and depression, with each item measured on a four-point scale.
Total scores for the anxiety and depression subscales range from 0 to 21.
A higher score indicates greater symptomatology
The PSS predicts both objective biological markers of stress and increased risk of disease in patients with higher stress levels.
BDI and BIS in combination have demonstrated that depression and/or binge eating may be mediating factors for the outcome of obesity
BDI and BIS in combination have demonstrated that depression and/or binge eating may be mediating factors for the outcome of obesity
The STAI provides data to help distinguish between anxiety and depression.
The FCQ-S consists of 15 items assessing: desire to eat, anticipation of positive reinforcement from eating, anticipation of negative reinforcement (reduction of negative affect) from eating, lack of control over eating, and (physiological) hunger; higher scores reflect stronger food craving.
Participants respond, using a Likert-type scale, how much each item is true of them right now.
Trait food craving will be assessed with the Food Craving Questionnaire-Trait (FCQ-T).
The FCQ-T consists of 39 items assessing: intentions/plans to eat, anticipation of positive reinforcement from eating, anticipation of negative reinforcement from eating, lack of control over eating, preoccupation with food, (physiological) hunger, emotions preceding or following food cravings or eating, environmental cues that may elicit food cravings, negative emotions including guilt experienced as a consequence of food cravings, and/or indulging such cravings; higher scores again indicate higher trait craving.
Individuals are asked to respond, using a Likert-type scale, how much each item is true of them in general.
A validated visual analogue scale (VAS) questionnaire will be completed in the fasting state.
The VAS consists of 100-mm lines with words anchored at each end describing extreme sensations of hunger, prospective consumption ("How much do you think you can eat?"), fullness, and satisfaction, as well as craving (sweet, salty, fatty or savory).
Patients will be asked to make a vertical mark across the line corresponding to their feelings.
Quantification will performed by measuring the distance from the left end of the line to the mark.
A validated questionnaire that assesses perceived subjective value attributed to expected/hypothetical foods and other primary reinforcers will be administered.
This variant of this questionnaire was initially developed by Dr. Goldstein to assess 'liking' and 'wanting' of expected drug rewards for patients with cocaine addiction.
The current assessment uses a modified version to assess 'liking' and 'wanting' for food.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Collection of data on Cushing's Syndrome participants before and over time after surgical, medication, and/or radiation therapy.
Time Frame: up to 10 years after treatment
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up to 10 years after treatment
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Collaborators and Investigators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Endocrine System Diseases
- Disease
- Endocrine Gland Neoplasms
- Hypothalamic Diseases
- Hyperpituitarism
- Pituitary Diseases
- Adenoma
- Adrenocortical Hyperfunction
- Adrenal Gland Diseases
- Pituitary Neoplasms
- Syndrome
- Cushing Syndrome
- ACTH-Secreting Pituitary Adenoma
- Pituitary ACTH Hypersecretion
Other Study ID Numbers
- 17-592
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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