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

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 90
Healthy Volunteers: Accepts Healthy Volunteers
View:

• Males and females 10-42 years old (subjects) who were previously diagnosed and had successful treatment of CD before the age of 21 years old. Patients who have undergone therapies other than surgical resection (such as radiation or medical treatment) will be eligible to participate.

• Normocortisolemia or hypocortisolemia at the time of the study (as documented within past 6 months of recruitment) documented as urine free cortisol or midnight/afternoon serum or salivary cortisol levels within or below the normal range.

• Patients or a legal guardian (in case of cognitively impaired adults or children) must provide assent/consent at the time of the recruitment.

• Family members (2- 90 yrs.) of patients with a family history of pituitary tumors and who agree to participate in the DNA/linkage analysis study.

Locations
United States
Maryland
National Institutes of Health Clinical Center
Recruiting
Bethesda
Contact Information
Primary
Margaret F Keil, C.R.N.P.
keilm@mail.nih.gov
(301) 435-3391
Time Frame
Start Date: March 4, 2019
Estimated Completion Date: January 3, 2040
Participants
Target number of participants: 600
Treatments
Family member
Family member of survivor of pediatric Cushing disease
Subjects
survivor of pediatric Cushing disease
Authors
Margaret F Keil
Sponsors
Leads: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

This content was sourced from clinicaltrials.gov

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