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

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ClinicalTrials.gov Identifier: NCT03364803
Recruitment Status : Recruiting
First Posted : December 7, 2017
Last Update Posted : September 10, 2020
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date December 1, 2017
First Posted Date December 7, 2017
Last Update Posted Date September 10, 2020
Actual Study Start Date November 28, 2017
Estimated Primary Completion Date November 28, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 1, 2017)
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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Cushing's Disease
  • Cushing Syndrome
  • Cushing Disease
Intervention
  • 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.
Study Groups/Cohorts Participants with Cushing's Syndrome
Interventions:
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 1, 2017)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 28, 2024
Estimated Primary Completion Date November 28, 2024   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 14 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Eliza Geer, MD 646-888-2627 geere@mskcc.org
Contact: Marc Cohen, MD 212-639-3769 cohenm2@mskcc.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03364803
Other Study ID Numbers 17-592
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor Memorial Sloan Kettering Cancer Center
Collaborators Not Provided
Investigators Not Provided
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date September 2020