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An Investigation of Pituitary Tumors and Related Hypothalmic Disorders

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ClinicalTrials.gov Identifier: NCT00001595
Recruitment Status : Recruiting
First Posted : November 4, 1999
Last Update Posted : August 2, 2021
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) )

Study Description
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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)<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
Panhypopituitarism Gigantism/Acromegaly Prolactinoma Cushing Disease

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, 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. (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 Design
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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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Patients with pituitary tumors or hypothalamic defects
Patients with pituitary tumors or hypothalamic defects


Outcome Measures
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Primary Outcome Measures :
  1. 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 pituitary gland oncogenesis and/or other defects.


Secondary Outcome Measures :
  1. To investigate the usefulness of a new MRI of the pituitary gland [ Time Frame: completed ]
    Comparison of MRI techniques to identify micro adenomas

  2. 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

  3. 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

  4. 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


Eligibility Criteria
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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:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects with known or suspected pituitary or hypothalamic tumors or related disorders. Family members (adult and pediatric; affected and unaffected) may be enrolled in the DNA linkage analysis part of this protocol.
Criteria
  • 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.

Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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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

Locations
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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   
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Christina Tatsi, M.D. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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: August 2, 2021
Last Verified: July 28, 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) ):
Developmental Defect
Oncogenesis
Evaluation and Management
Psychological
Cushing Disease
Additional relevant MeSH terms:
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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