Status:
RECRUITING
Long-Term Follow-Up of Survivors of Pediatric Cushing Disease
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Cushing Disease
Eligibility:
All Genders
2-90 years
Brief 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 c...
Detailed Description
Objective: Cushing Disease (CD) describes the state of hypercortisolemia secondary to cortisol producing pituitary adenomas. The rarity of the disease (2-5 new cases per million, 1 out of 10 in child...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- 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 or documented panhypopituitarism (on glucocorticoid replacement).
- 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.
- EXCLUSION CRITERIA:
- Pregnancy
- Patients with any medical, physical, psychiatric, or social conditions, which, in the opinion of the investigators, would make participation in this protocol not in their best interest, will be excluded from the on-site visit of the study. Patients who are critically ill, unstable, or with severe organ failure that may affect/limit the endocrine evaluation and place unsustainable demands on Clinical Center or NICHD resources will be excluded. They will still be offered the opportunity to participate in the online questionnaire part of the study.
Exclusion
Key Trial Info
Start Date :
March 4 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 3 2040
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT03831958
Start Date
March 4 2019
End Date
January 3 2040
Last Update
December 2 2025
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892