Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001595
Status:
RECRUITING
Last Update Posted:
2024-06-07
First Post:
1999-11-03
Brief Title:
An Investigation of Pituitary Tumors and Related Hypothalmic Disorders
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Clinical and Genetic Investigation of Pituitary and HYPOTHALAMIC Tumors and Related Disorders
Status:
RECRUITING
Status Verified Date:
2024-10-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 genes involved in the pathogenesis of these tumors are largely not known their possible association with other developmental defects or inheritance patterns has not been investigated The present study serves as a i screeningtraining 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
iTABtraining our fellows and students in the identification of genetic defects associated with pituitary tumor formation and
iiTABteaching our fellows and students the recognition management and complications of pituitary tumors
As a research study this protocol aims at
iTABdeveloping 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
iiTABIdentifying 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
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
iTABtraining our fellows and students in the identification of genetic defects associated with pituitary tumor formation and
iiTABteaching our fellows and students the recognition management and complications of pituitary tumors
As a research study this protocol aims at
iTABdeveloping 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
iiTABIdentifying 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
Detailed Description:
Study DescriptionTAB
This protocol aims to evaluate subjects with tumors of the hypothalamic pituitary unit to identify genetic components of pituitary and hypothalamic oncogenesis to develop new clinical studies for the recognition and therapy of pituitary tumors and to investigate the psychological effects of cortisol secretion
ObjectivesTAB
Primary Objective
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 andor other defects
Secondary Objectives
To serve as a screening protocol for future studies on the treatment and clinical follow up of our patients with pituitary tumors it is our hope that the protocol will continue to be a vehicle for the development of more related clinical studies
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
Endpoints
TAB
Primary Endpoint
Molecular genetic testing whole exome sequencing
Secondary Endpoints
Pre-post treatment comparison of research variables related to pituitaryhypothalamic tumors and comorbidities
Cognitive behavioral psychological and patient-reported outcomes
This protocol aims to evaluate subjects with tumors of the hypothalamic pituitary unit to identify genetic components of pituitary and hypothalamic oncogenesis to develop new clinical studies for the recognition and therapy of pituitary tumors and to investigate the psychological effects of cortisol secretion
ObjectivesTAB
Primary Objective
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 andor other defects
Secondary Objectives
To serve as a screening protocol for future studies on the treatment and clinical follow up of our patients with pituitary tumors it is our hope that the protocol will continue to be a vehicle for the development of more related clinical studies
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
Endpoints
TAB
Primary Endpoint
Molecular genetic testing whole exome sequencing
Secondary Endpoints
Pre-post treatment comparison of research variables related to pituitaryhypothalamic tumors and comorbidities
Cognitive behavioral psychological and patient-reported outcomes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 97-CH-0076 | None | None | None |