Long-term effects of childhood Cushing disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to investigate the long-term consequences of Cushing disease in individuals who were diagnosed before the age of 21 and have since been cured. Participants aged 10-42 will undergo a medical history screening and complete an online survey regarding their physical and mental health. Follow-up visits will occur at five-year intervals to assess various health outcomes related to their previous exposure to high cortisol levels. The study seeks to clarify the persistent complications associated with childhood hypercortisolemia, including metabolic and endocrine issues.

Why it matters

Who can join: the full rules

* INCLUSION CRITERIA:

  1. Males and females \>=5 years of age or older (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.
  2. 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).
  3. Patients or a legal guardian (in case of cognitively impaired adults or children) must provide assent/consent at the time of the recruitment.

     Or,
  4. 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:

1. Pregnancy: Pregnancy will be evaluated only in participants of reproductive age (from 10 years old until 60 years of age unless menopause has already occurred per clinical report of the participant).

   For participants enrolled as external participants or under the Linkage study (where research activities include no more than blood draws), any female who could possibly become pregnant will be screened using clinical criteria (history, with pregnancy testing only if indicated) for exclusion and this information will be documented in the consent process note in EMR. If a participant has initially been registered as external location and then presents on-site, then pregnancy test will be performed if within the reproductive age group.
2. 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.

Where it's running

• National Institutes of Health Clinical Center
  Bethesda, Maryland, United States Recruiting

Study contacts

• Principal investigator: Deborah P Merke, M.D. — Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Study coordinator: Deborah P Merke, M.D.
• Email: dmerke@nih.gov
• Phone: (301) 496-0718

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Intraoperative contrast-enhanced ultrasound to locate pituitary adenomas in Cushing's disease

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• Fimepinostat treatment for Cushing Disease

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.