Data Collection for Cushing's Syndrome

Recruiting at 10 trial locations

Overseen By Marc Cohen, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Iatrogenic Cushing's

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand the long-term outcomes for individuals with Cushing's syndrome. It tracks patients during their regular medical care and collects data to assess how treatments impact their quality of life and mental health. Participants will complete various questionnaires, including the Barratt's Impulsivity Scale (BIS), Beck Depression Inventory (BDI), and Cushing's Quality of Life Questionnaire (QoL), to evaluate stress, anxiety, depression, and food cravings. Individuals diagnosed with active or previously treated Cushing's syndrome due to specific tumors or conditions may be suitable for this study. As an unphased trial, this study allows participants to contribute to a deeper understanding of Cushing's syndrome and its treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to gather comprehensive data on how Cushing's Syndrome affects patients' mental health, quality of life, and stress levels. Unlike standard treatments that primarily focus on reducing cortisol levels, this trial uses various psychological and quality of life assessments like the Barratt's Impulsivity Scale and Beck Depression Inventory to understand the broader impact of the syndrome. By exploring these dimensions, the trial could reveal insights into managing the emotional and psychological challenges of Cushing's, potentially leading to more holistic treatment approaches in the future.

Are You a Good Fit for This Trial?

Inclusion Criteria

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Routine Care

Participants are followed during the course of their routine care for Cushing's syndrome

Varies

Follow-up

Participants are monitored for long-term outcomes and data is collected for the registry

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Barratt's Impulsivity Scale (BIS)
• Beck Depression Inventory (BDI)
• Cushing's QoL (Quality of Life Questionnaire)
• Hospital Anxiety and Depression Scale (HADS)
• Nottingham Health Profile (NHP)
• Perceived Stress Scale (PSS)
• Sensitivity to Reinforcement of Addictive and other Primary Rewards (STRAP-R) food variant
• State Food Craving Questionnaire-State (FCQ-S)
• State-Trait Anxiety Inventory (STAI)
• Trait Food Craving Questionnaire-Trait (FCQ-T)
• Visual Analogue Scale (VAS)

How Is the Trial Designed?

Group I: Participants with Cushing's Syndrome Experimental Treatment 11 Interventions

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+