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An Investigation of Pituitary Tumors and Related Hypothalmic Disorders

Descriptive Information
Brief Title † An Investigation of Pituitary Tumors and Related Hypothalmic Disorders
Official Title † A Clinical and Genetic Investigation of Pituitary and HYPOTHALAMIC Tumors and Related Disorders
Brief Summary There is a variety of tumors affecting the pituitary gland in childhood; some of these tumors (eg craniopharyngioma) are included among the most common central nervous system tumors in childhood. The gene(s) involved in the pathogenesis of these tumors are largely not known; their possible association with other developmental defects or inheritance pattern(s) has not been investigated. The present study serves as a (i) screening/training, and, (ii) a research protocol. As a screening and training study, this protocol allows our Institute to admit children with tumors of the hypothalamic-pituitary unit to the pediatric endocrine clinics and wards of the NIH Clinical Center for the purposes of (i)training our fellows and students in the identification of genetic defects associated with pituitary tumor formation, and (ii)teaching our fellows and students the recognition, management and complications of pituitary tumors As a research study, this protocol aims at (i)developing new clinical studies for the recognition and therapy of pituitary tumors; as an example, two new studies have emerged within the context of this protocol: (a) investigation of a new research magnetic resonance imaging (MRI) tool and its usefulness in the identification of pituitary tumors, and (b) investigation of the psychological effects of cortisol secretion in pediatric patients with Cushing disease. Continuation of this protocol will eventually lead to new, separate protocols that will address all aspects of diagnosis of pituitary tumors and their therapy in childhood. (ii)Identifying the genetic components of pituitary oncogenesis; those will be investigated by (a) studying the inheritance pattern of pituitary tumors in childhood and their possible association with other conditions in the families of the patients, and (ii) collecting tumor tissues and examining their molecular genetics. As with the clinical studies, the present protocol may help generate ideas for future studies on the treatment and clinical follow up of pediatric patients with tumors of the pituitary gland and, thus, lead to the development of better therapeutic regimens for these neoplasms.
Detailed Description There are a variety of tumors affecting the pituitary gland; The gene(s) involved in the pathogenesis of these tumors are largely not known; their possible association with other developmental defects or inheritance pattern(s) has not been investigated. The present study serves as a (i) screening/training, and, (ii) a research protocol. As a screening and training study, this protocol allows our Institute to admit patients with tumors of the hypothalamic-pituitary unit to the clinics and wards of the NIH Clinical Center for the purposes of: (i) Training our fellows and students in the identification of genetic defects associated with pituitary tumor formation, and (ii) Teaching our fellows and students the recognition, management and complications of pituitary tumors As a research study, this protocol aims at: (i) Developing new clinical studies for the recognition and therapy of pituitary tumors; as an example, two new studies have emerged within the context of this protocol: (a) investigation of a new research magnetic resonance imaging (MRI) tool and its usefulness in the identification of pituitary tumors, and (b) investigation of the psychological effects of cortisol secretion in pediatric (only) patients with Cushing disease. Continuation of this protocol will eventually lead to new, separate protocols that will address all aspects of diagnosis of pituitary tumors and their therapy in childhood. (ii) Identifying the genetic components of pituitary oncogenesis; those will be investigated by (a) studying the inheritance pattern of pituitary tumors in childhood and their possible association with other conditions in the families of the patients, and (ii) collecting tumor tissues and examining their molecular genetics. As with the clinical studies, the present protocol may help generate ideas for future studies on the treatment and clinical follow up of patients with tumors of the pituitary gland and, thus, lead to the development of better therapeutic regimens for these neoplasms.
Study Phase N/A
Study Type † Observational
Study Design †
Primary Outcome Measure †
Secondary Outcome Measure †
Condition † Abnormalities Craniopharyngioma Cushing's Syndrome Endocrine Disease Pituitary Neoplasm
Intervention †
Study Arms / Comparison Groups
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status †
Estimated Enrollment † 1500
Start Date † February 13, 1997
Completion Date
Primary Completion Date
Eligibility Criteria † - INCLUSION CRITERIA: A. The following criteria must be met for all, who enter the study: - Age 3-70 years - Evidence for the existence of a tumor of the hypothalamic-pituitary unit, as indicated by previously obtained imaging studies or biochemical investigation of the hypothalamo-hypophyseal function. Patients may withdraw from the study at any time. B. For family members studied for linkage analysis, the following criteria must be met: - Any age - Member of a kindred suspected of having an inherited form of pituitary neoplasia, as evidenced by results of a patient studied under A (above).
Gender All
Ages 3 Years - 70 Years
Accepts Healthy Volunteers No
Contacts †† Margaret F Keil, C.R.N.P., (301) 435-3391, keilm@mail.nih.gov
Location Countries † United States
Administrative Information
NCT ID † NCT00001595
Organization ID 970076
Secondary IDs †† 97-CH-0076
Responsible Party Sponsor
Study Sponsor † Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators ††
Investigators † Principal Investigator: Maya B Lodish, M.D., Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information Provided By
Verification Date June 8, 2017
First Received Date † November 3, 1999
Last Updated Date June 13, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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