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 : January 20, 2021
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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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| Panhypopituitarism Gigantism/Acromegaly Prolactinoma Cushing Disease |
There are a variety of tumors affecting the pituitary gland and hypothalamus; 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, and, (ii) an observational research protocol.
As a screening 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 determining eligibility for CC protocols.
As an observational research study, this protocol aims at:
Developing new clinical studies for the recognition and therapy of pituitary tumors; as an example, a new study had emerged within the context of this protocol: investigation of the psychological effects of cortisol secretion in pediatric (only) patients with Cushing disease, and (c) to study (longitudinally) whether CS in pediatric patients is also associated with a hypercoagulable state. 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.
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, collecting tumor tissues and examining their molecular genetics, and using whole exome/genome sequencing (WE/GS) and related techniques in identifying genetic predisposition or causative factors.
As with 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 : | 2000 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | A Clinical and Genetic Investigation of Pituitary and HYPOTHALAMIC Tumors and Related Disorders |
| Actual Study Start Date : | April 21, 1997 |
| Group/Cohort |
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Patients with pituitary tumors or hypothalamic defects
Patients with pituitary tumors or hypothalamic defects
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- Molecular genetic testing, whole exome sequencing [ Time Frame: ongoing ]To collect peripheral blood DNA samples and tumor tissues and examine the molecular genetics of the specimens, in an effort to elucidate developmental pathways leading to pituitarygland oncogenesis and/or other defects.
- To evaluate the cognitive, psychological, and patient-reported health status of mental and social well-being and symptoms of adrenal insufficiency associated with Cushing syndrome in children with this disease. [ Time Frame: ongoing ]Descriptive study of cognitive, psychological, and patient-reported health status of mental and social well-being associated with Cushing and after treatment
- To investigate the usefulness of a new MRI of the pituitary gland [ Time Frame: completed ]Comparison of MRI techniques to identify micro adenomas
- to collect peripheral blood DNA samples and tumor tissues and examine the molecular genetics of the specimens, in an effort to elucidate developmental pathways leading to pituitary gland oncogenesis and/or other defects [ Time Frame: ongoing ]Genetic studies of pituitary and hypothalamic tumors or related disorders
- To identify the clinical and genetic features of pituitary tumors by investigating their inheritance pattern and possible association with other conditions in the families of the patients [ Time Frame: ongoing ]Genetic studies of pituitary and hypothalamic tumors or related disorders
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 3 Years to 70 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
- INCLUSION CRITERIA:
- Patients eligible for the study (3- 70 years old).
- 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.
- Family members (any age) of patients with a family history of tumors and who will agree to participate in the DNA/linkage analysis study.
- Member of a kindred suspected of having an inherited form of pituitary neoplasia, as evidenced by results of a patient studied under A (above).
EXCLUSION CRITERIA:
-Children younger than 3 years cannot be admitted and treated at the NIH Clinical Center due to lack of specialized infant and small
children units; likewise, older patients may not be admitted due to lack of appropriate geriatric care.
-Pregnant women are excluded from enrollment.
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: Christina Tatsi, M.D. | (301) 451-7170 | christina.tatsi3@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: | Christina Tatsi, M.D. | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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 |
| Other Study ID Numbers: |
970076 97-CH-0076 |
| First Posted: | November 4, 1999 Key Record Dates |
| Last Update Posted: | January 20, 2021 |
| Last Verified: | December 17, 2020 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Developmental Defect Oncogenesis Evaluation and Management Psychological Cushing Disease |
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Acromegaly ACTH-Secreting Pituitary Adenoma Prolactinoma Gigantism Pituitary ACTH Hypersecretion Pituitary Diseases Hypothalamic Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Endocrine System Diseases Bone Diseases, Endocrine |
Bone Diseases Musculoskeletal Diseases Hyperpituitarism Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Pituitary Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Bone Diseases, Developmental |