Clinical trial · Observational
Collecting Information About Treatment Results for Patients With Cushing's Syndrome
Treatment Outcomes for Patients With Cushing's Syndrome: a Prospective Data Collection Study
NCT03364803CI-TRIAL-00096746recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cushing Disease | — | UNRESOLVED | — |
| Cushing's Disease | — | UNRESOLVED | — |
| Cushing Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (11)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Barratt's Impulsivity Scale (BIS) | Other | — | UNRESOLVED |
| Beck Depression Inventory (BDI) | Other | — | UNRESOLVED |
| Cushing's QoL (Quality of Life Questionnaire) | Other | — | UNRESOLVED |
| Hospital Anxiety and Depression Scale (HADS) | Other | — | UNRESOLVED |
| Nottingham Health Profile (NHP) | Other | — | UNRESOLVED |
| Perceived Stress Scale (PSS) | Other | — | UNRESOLVED |
| Sensitivity to Reinforcement of Addictive and other Primary Rewards (STRAP-R) food variant | Other | — | UNRESOLVED |
| State Food Craving Questionnaire-State (FCQ-S) |
Design
Arms and outcomes
Arms (1)
- label
- Participants with Cushing's Syndrome
- interventionNames
- 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
Primary outcomes (1)
- measure
- Collection of data on Cushing's Syndrome participants before and over time after surgical, medication, and/or radiation therapy.
- timeFrame
- up to 10 years after treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * Patients with a diagnosis of iatrogenic Cushing's.
References
Publications (0)
Data not yet available
No reference posted for this study.