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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03364803
Recruitment Status : Recruiting
First Posted : December 7, 2017
Last Update Posted : December 10, 2019
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment
Cushing's Disease Cushing Syndrome Cushing Disease 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

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Treatment Outcomes for Patients With Cushing's Syndrome: a Prospective Data Collection Study
Actual Study Start Date : November 28, 2017
Estimated Primary Completion Date : November 28, 2024
Estimated Study Completion Date : November 28, 2024


Group/Cohort Intervention/treatment
Participants with Cushing's Syndrome Other: 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: 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: 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: 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: 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: 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: State-Trait Anxiety Inventory (STAI)
The STAI provides data to help distinguish between anxiety and depression.

Other: 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: 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: 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: Sensitivity to Reinforcement of Addictive and other Primary Rewards (STRAP-R) food variant
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.




Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03364803


Contacts
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Contact: Eliza Geer, MD 646-888-2627 geere@mskcc.org
Contact: Marc Cohen, MD 212-639-3769 cohenm2@mskcc.org

Locations
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United States, New York
Memorial Sloan - Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Eliza Geer, MD    646-888-2627      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03364803    
Other Study ID Numbers: 17-592
First Posted: December 7, 2017    Key Record Dates
Last Update Posted: December 10, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
Cushing Syndrome
Cushing's Disease
Cushing Disease
17-592
Memorial Sloan Kettering Cancer Center
Additional relevant MeSH terms:
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ACTH-Secreting Pituitary Adenoma
Pituitary ACTH Hypersecretion
Cushing Syndrome
Syndrome
Disease
Pathologic Processes
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pituitary Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site