Investigation of pituitary tumors and related disorders in children
A Clinical and Genetic Investigation of Pituitary and Hypothalamic Tumors and Related Disorders
National Institutes of Health Clinical Center (CC) · NCT00001595
This study is trying to find out more about pituitary tumors in children by looking at their genes and how these tumors affect their health and emotions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 2 Years to 70 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) (nih) |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT00001595 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on children with tumors affecting the hypothalamic-pituitary unit, aiming to identify genetic factors involved in pituitary tumor formation and related disorders. It serves both as a training protocol for medical fellows and as a research initiative to collect DNA samples and tumor tissues for molecular genetic testing. The study also evaluates the psychological effects of conditions like Cushing syndrome on affected children. By understanding these tumors better, the study hopes to pave the way for future clinical trials and improved management strategies.
Who should consider this trial
Good fit: Ideal candidates include children aged 3 to 70 years with confirmed tumors of the hypothalamic-pituitary unit or those with a family history of such tumors.
Not a fit: Patients who are pregnant will not benefit from this study due to exclusion criteria.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and management of pituitary tumors in children, potentially improving their health outcomes.
How similar studies have performed: While this study builds on existing knowledge, it aims to explore novel genetic components and psychological impacts, indicating a combination of established and innovative approaches.
Eligibility criteria
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
1. Stated willingness to comply with all study procedures and availability for the duration of the study.
2. Male or female with:
1. Evidence for the existence of a tumor of the hypothalamic-pituitary unit or related disorder, as indicated by previously obtained imaging studies or biochemical investigation of the hypothalamo-hypophyseal function (aged 2 years to 70 years)
or
2. Family members (any age) of patients with a family history of tumors of the hypothalamic-pituitary unit or related disorders as part of the linkage part of the study, or
3. Members (any age) of a kindred suspected of having an inherited form of neoplasia of the hypothalamic-pituitary unit or related disorder, as evidenced by results of a patient enrolled in this protocol, as part of the linkage part of the study
3. Ability of the subject or LAR to understand and the willingness to sign a written informed consent document.
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this study:
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 condition, which, in the opinion of the investigators, would make participation in this protocol not in their best interest, will be excluded from the study.
3. Patients who are critically ill, unstable, or with severe organ failure that may affect/limit the endocrine evaluation and place unsustainable demands on CC or NICHD resources may be excluded.
Where this trial is running
Bethesda, Maryland
- 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: Ka Wing J Lam
- Email: kawing.lam@nih.gov
- Phone: (301) 402-8084
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Panhypopituitarism, Gigantism/Acromegaly, Prolactinoma, Cushing Disease, Developmental Defect, Oncogenesis, Evaluation and Management, Psychological