Long-Term Follow-Up of Survivors of Pediatric Cushing Disease

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study ID
NCT03831958
Status
Recruiting
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Conditions

  • Cushing Disease

Eligibility Criteria

Sex
ALL
Age
2 Years - 90 Years
Healthy Volunteers
Accepted

Study Details

Background: The pituitary gland produces hormones. A tumor in this gland can cause it to produce too much of the hormone cortisol. Too much cortisol in the body causes Cushing disease. This disease causes many problems. Some of these problems might persist after the disease is cured. Objective: To find out the long-term effects of exposure to high levels of cortisol during childhood and adolescence. Eligibility: People ages 10-42years who were diagnosed with Cushing disease before age 21 and are now cured and have normal or low cortisol levels People related to someone with Cushing disease Design: Participants will be screened with a medical history. Participants will complete an online survey. This will include questions about their or their child s physical and mental health. All participants will be seen at 5 -year intervals after cure of Cushing disease (5yr, 10yr, 15yr, 20yr (last visit)) Participants who have a relative with Cushing disease will have a medical history and blood tests or cheek swabs. Participants who have the disease will have: Physical exam Blood tests Cheek swab DXA scan: A machine will x-ray the participant s body to measure bone mineral content. For participants who are still growing, a hand x-ray Participants with the disease may also have: Hormone stimulation test: Participants will get a hormone or another substance that will be measured. Serial hormone sampling: Participants blood will be measured several times through a thin plastic tube in an arm vein. Urine tests: Participants urine may be collected over 24 hours. MRI: Participants may have a dye injected into a vein. They will lie on a table that slides into a machine. The machine will take pictures of the body. ...

Key Dates

Start date
Mar 4, 2019
Status verified
Apr 2026
Primary completion
Jan 3, 2040
Completion
Jan 3, 2040

Study Design

Enrollment
600 participants (estimated)

Arms

  • Arm: Family member
    Family member of survivor of pediatric Cushing disease
  • Arm: Subjects
    survivor of pediatric Cushing disease

Primary Outcome Measure

Difference in body mass index z-score of subjects previously treated for Cushing disease compared to general population [ Time Frame: baseline, 5, 10, 15, 20 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
[email protected]
800-411-1222

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By research site
National Institutes of Health Clinical Center· Bethesda, MD

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