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An Investigation of Pituitary Tumors and Related Hypothalmic Disorders

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) )
ClinicalTrials.gov Identifier:
NCT00001595
First received: November 3, 1999
Last updated: November 11, 2014
Last verified: March 2014

November 3, 1999
November 11, 2014
February 1997
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Complete list of historical versions of study NCT00001595 on ClinicalTrials.gov Archive Site
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An Investigation of Pituitary Tumors and Related Hypothalmic Disorders
A Clinical and Genetic Investigation of Pituitary Tumors and Related Hypothalmic Disorders

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)< TAB> training our fellows and students in the identification of genetic defects associated with pituitary tumor formation, and

(ii)< TAB> teaching our fellows and students the recognition, management and complications of pituitary tumors

As a research study, this protocol aims at

(i)< TAB> 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)< TAB> 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.

.< TAB>

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.

Observational
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  • Abnormalities
  • Craniopharyngioma
  • Cushing's Syndrome
  • Endocrine Disease
  • Pituitary Neoplasm
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1500
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  • 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).

Both
3 Years to 70 Years
No
Contact: Maya B Lodish, M.D. (301) 451-7175 lodishma@mail.nih.gov
United States
 
NCT00001595
970076, 97-CH-0076
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National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) )
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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Principal Investigator: Maya B Lodish, M.D. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institutes of Health Clinical Center (CC)
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP