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Sponsored by: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00001595 |
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.
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Condition |
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Abnormalities Craniopharyngioma Cushing's Syndrome Endocrine Disease Pituitary Neoplasm |
Study Type: | Observational |
Official Title: | A Clinical and Genetic Investigation of Pituitary Tumors and Related Hypothalmic Disorders |
Estimated Enrollment: | 1500 |
Study Start Date: | February 1997 |
There is 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 gene 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; and (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 (b) 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.
Ages Eligible for Study: | 3 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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).
Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
Contact: TTY | 1-866-411-1010 |
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
Bethesda, Maryland, United States, 20892 |
Study ID Numbers: | 970076, 97-CH-0076 |
Study First Received: | November 3, 1999 |
Last Updated: | November 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00001595 |
Health Authority: | United States: Federal Government |
Oncogenesis Adenoma Craniopharyngioma Cushing Syndrome |
Homeobox-Containing Genes Developmental Defect Pituitary Gland |
Hypothalamic Diseases Pituitary Diseases Cushing Syndrome Central Nervous System Diseases Endocrine System Diseases Adrenal Gland Diseases Central Nervous System Neoplasms Pituitary Neoplasms Brain Diseases Adrenocortical Hyperfunction Supratentorial Neoplasms |
Neuroectodermal Tumors Brain Neoplasms Neoplasms, Germ Cell and Embryonal Craniopharyngioma Neuroepithelioma Endocrinopathy Congenital Abnormalities Adenoma Nervous System Neoplasms Endocrine Gland Neoplasms |
Neoplasms Pathologic Processes Disease Neoplasms by Site Neoplasms by Histologic Type |
Hypothalamic Neoplasms Syndrome Nervous System Diseases Neoplasms, Nerve Tissue |