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NCT00001595 · ClinicalTrials.gov registry record

An Investigation of Pituitary Tumors and Related Hypothalmic Disorders

A clinical trial of Cushing Disease and Panhypopituitarism, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

Recruiting
Registry status
2,000
Enrollment target
1
Study location

NCT00001595: Recruiting study of Cushing Disease and Panhypopituitarism, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

NCT00001595 is a study of Cushing Disease and Panhypopituitarism that is actively recruiting participants, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 2,000 participants, above the 143-participant average among 8 other Cushing Disease trials with a reported enrollment target (1299% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00001595, a study of Cushing Disease and Panhypopituitarism, is actively recruiting participants, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

RECRUITING
Registry status
2,000 participants
Enrollment target
1
Study location

Study 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) 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 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

Primary Outcome

To collect peripheral blood 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.

Interventions

  • PROCEDURE MRI
  • PROCEDURE Tissue specimen collection

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center - Bethesda

Trial Details

FieldValue
Enrollment Target 2,000 participants
Start Date 1997-04-21

What NCT00001595 shows while recruiting

NCT00001595 is an observational study that tracks outcomes without assigning an intervention. Its 2,000 participants enrollment target places it among the larger protocols in the corpus, above the 143-participant average among 8 other Cushing Disease trials with a reported enrollment target (1299% higher).

The record links to 4 conditions, with Cushing Disease appearing as the primary indexed condition, and to 2 interventions - of which MRI is the first listed.

NCT00001595 reports a single indexed study location in Maryland.

Frequently Asked Questions

What is clinical trial NCT00001595 about?

NCT00001595 is a clinical study titled "An 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 associati...

What is the current status of trial NCT00001595?

This trial is currently recruiting. The enrollment target is 2,000 participants. The study started on 1997-04-21.

What conditions does trial NCT00001595 study?

This clinical trial studies the following conditions: Cushing Disease, Panhypopituitarism, Gigantism/Acromegaly, Prolactinoma.

What interventions are being tested in trial NCT00001595?

The interventions under investigation include: MRI (PROCEDURE), Tissue specimen collection (PROCEDURE).

Who is sponsoring clinical trial NCT00001595?

This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00001595 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Cushing Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00001595's enrollment target sits among peer trials

2,000 1st of 8 higher than 8 of 8 other Cushing Disease trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Cushing Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00001595, the US trial registry maintained by the National Library of Medicine. NCT00001595 (large enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.