Cushing's DiseaseNCT03364803
Collecting Information About Treatment Results for Patients With Cushing's Syndrome
An observational study of Cushing's Disease and Cushing Syndrome, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Cushing's Disease, Cushing Syndrome, Cushing Disease
- What is being tested?
- Cushing's QoL (Quality of Life Questionnaire), Nottingham Health Profile (NHP) and Hospital Anxiety and Depression Scale (HADS)
- How many people
- 300 participants
- Where
- 7 sitesUnited States
- Study dates
- 28 Nov 2017to 28 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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 (in the case of pituitary Cushing's). 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 CS (morning cortisol >1.8 µg/dL after 1 mg overnight) and the presence of an adrenal adenoma.
- 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.
Who cannot join
- Patients with a diagnosis of iatrogenic Cushing's.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Eliza Geer, MD, 646-888-2627
- Recruiting
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activity)
Commack, New York, 11725
Eliza Geer, MD, 646-888-2627
- Recruiting
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
Eliza Geer, MD, 646-888-2627
- Recruiting
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
Eliza Geer, MD, 646-888-2627
- Recruiting
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Eliza Geer, MD, 646-888-2627
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Eliza Geer, MD, 646-888-2627
- Recruiting
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, 11553
Eliza Geer, MD, 646-888-2627
About this study
Official title: Treatment Outcomes for Patients With Cushing's Syndrome: a Prospective Data Collection Study
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.
- Conditions
- Cushing's Disease, Cushing Syndrome, Cushing Disease
- Being tested
- 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)
- Keywords
- Cushing Syndrome, Cushing's Disease, Cushing Disease, 17-592, Memorial Sloan Kettering Cancer Center
- Medical subject headings
- Pituitary ACTH Hypersecretion, Cushing Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cushing's QoL (Quality of Life Questionnaire)Other
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
Nottingham Health Profile (NHP)Other
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
Hospital Anxiety and Depression Scale (HADS)Other
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
Perceived Stress Scale (PSS)Other
The PSS predicts both objective biological markers of stress and increased risk of disease in patients with higher stress levels.
Barratt's Impulsivity Scale (BIS)Other
BDI and BIS in combination have demonstrated that depression and/or binge eating may be mediating factors for the outcome of obesity
Beck Depression Inventory (BDI)Other
BDI and BIS in combination have demonstrated that depression and/or binge eating may be mediating factors for the outcome of obesity
State-Trait Anxiety Inventory (STAI)Other
The STAI provides data to help distinguish between anxiety and depression.
State Food Craving Questionnaire-State (FCQ-S)Other
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 Questionnaire-Trait (FCQ-T)Other
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.
Visual Analogue Scale (VAS)Other
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.
Sensitivity to Reinforcement of Addictive and other Primary Rewards (STRAP-R) food variantOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Cushing's Syndrome | Not described Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of data on Cushing's Syndrome participants before and over time after surgical, medication, and/or radiation therapy.
Measured: up to 10 years after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2017
- Study start28 Nov 2017
- Primary completion28 Nov 2026 (estimated)
- Study completion28 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cushing's DiseaseStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03364803
- Sponsor's protocol ID
- 17-592
- Status last verified
- Oct 2026
- First submitted
- 1 Dec 2017
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Outcomes for Patients With Cushing's Syndrome: a Prospective Data Collection Study
- ClinicalTrials.gov ID
- NCT03364803
- Acronym / sponsor ID
- 17-592
- Conditions
- Cushing's Disease, Cushing Syndrome, Cushing Disease
- Keywords
- Cushing Syndrome, Cushing's Disease, Cushing Disease, 17-592, Memorial Sloan Kettering Cancer Center
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 28 Nov 2017 (actual)
- Primary completion
- 28 Nov 2026 (estimated)
- Study completion
- 28 Nov 2026 (estimated)
- First posted
- 7 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Cushing's Syndrome | – | 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 |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
- 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.
Key exclusion criteria (1 listed)
- Patients with a diagnosis of iatrogenic Cushing's.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cushing's QoL (Quality of Life Questionnaire)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 | Other | Participants with Cushing's Syndrome |
| Nottingham Health Profile (NHP)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 | Other | Participants with Cushing's Syndrome |
| Hospital Anxiety and Depression Scale (HADS)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 | Other | Participants with Cushing's Syndrome |
| Perceived Stress Scale (PSS)The PSS predicts both objective biological markers of stress and increased risk of disease in patients with higher stress levels. | Other | Participants with Cushing's Syndrome |
| Barratt's Impulsivity Scale (BIS)BDI and BIS in combination have demonstrated that depression and/or binge eating may be mediating factors for the outcome of obesity | Other | Participants with Cushing's Syndrome |
| Beck Depression Inventory (BDI)BDI and BIS in combination have demonstrated that depression and/or binge eating may be mediating factors for the outcome of obesity | Other | Participants with Cushing's Syndrome |
| State-Trait Anxiety Inventory (STAI)The STAI provides data to help distinguish between anxiety and depression. | Other | Participants with Cushing's Syndrome |
| State Food Craving Questionnaire-State (FCQ-S)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. | Other | Participants with Cushing's Syndrome |
| Trait Food Craving Questionnaire-Trait (FCQ-T)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. | Other | Participants with Cushing's Syndrome |
| Visual Analogue Scale (VAS)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. | Other | Participants with Cushing's Syndrome |
| Sensitivity to Reinforcement of Addictive and other Primary Rewards (STRAP-R) food variantA 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. | Other | Participants with Cushing's Syndrome |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cushing's Disease and Cushing Syndrome, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eliza Geer, MD (646-888-2627, geere@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.