An Investigation of Pituitary Tumors and Related Hypothalmic Disorders
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| ClinicalTrials.gov Identifier: NCT00001595 |
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Recruitment Status :
Recruiting
First Posted : November 4, 1999
Last Update Posted : June 15, 2018
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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.
| Condition or disease |
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| Abnormalities Craniopharyngioma Cushing's Syndrome Endocrine Disease Pituitary Neoplasm |
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 Type : | Observational |
| Estimated Enrollment : | 1500 participants |
| Official Title: | A Clinical and Genetic Investigation of Pituitary and HYPOTHALAMIC Tumors and Related Disorders |
| Study Start Date : | February 13, 1997 |
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| Ages Eligible for Study: | 3 Years to 70 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001595
| Contact: Margaret F Keil, C.R.N.P. | (301) 435-3391 | keilm@mail.nih.gov | |
| Contact: Constantine A Stratakis, M.D. | (301) 594-5984 | stratakc@mail.nih.gov |
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 prpl@cc.nih.gov | |
| Principal Investigator: | Constantine A Stratakis, M.D. | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| ClinicalTrials.gov Identifier: | NCT00001595 History of Changes |
| Other Study ID Numbers: |
970076 97-CH-0076 |
| First Posted: | November 4, 1999 Key Record Dates |
| Last Update Posted: | June 15, 2018 |
| Last Verified: | February 21, 2018 |
Keywords provided by National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) ):
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Oncogenesis Adenoma Craniopharyngioma Cushing Syndrome |
Homeobox-Containing Genes Developmental Defect Pituitary Gland |
Additional relevant MeSH terms:
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Cushing Syndrome Pituitary Diseases Craniopharyngioma Adamantinoma Pituitary Neoplasms Endocrine System Diseases Hypothalamic Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Adrenocortical Hyperfunction Adrenal Gland Diseases Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Bone Neoplasms Neoplasms by Site Bone Diseases Musculoskeletal Diseases Endocrine Gland Neoplasms Hypothalamic Neoplasms Supratentorial Neoplasms Brain Neoplasms Central Nervous System Neoplasms Nervous System Neoplasms |