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An Investigation of Pituitary Tumors and Related Hypothalmic Disorders

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Amendment history

The 50 most recent of 388 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor

    Eligibility criteria expanded, about 10 words

    Secondary endpoints: details revised at 1 of 4 entries; Study description revised; Publications: details revised at 17 of 17 entries

    Show what changed: Eligibility criteria
    * INCLUSION CRITERIA: In order to be eligible to participate i [...] udy, an individual must meet all of the following criteria: 1. Stated willingness to comply with all study procedures and availability for the duration of the study. 2. Male or female with: 1. Evidence for the existence of a tumor of the hypothalamic-pi [...] othalamo-hypophyseal function (aged 2 years to 70 years) or 2. Family members (any age) of patients with a family history o [...] ated disorders as part of the linkage part of the study, or 3. Members (any age) of a kindred suspected of having an inheri [...] in this protocol, as part of the linka [...]
    Show what changed: Study description
    Study Description:<TAB>\ This protocol aims to evaluate subjects with tumors of the [...] the psychological effects of cortisol secretion. Objectives:<TAB>\ Primary Objective: To collect peripheral blood samples and [...] ing syndrome (CS) in children with this disease. Endpoints: <TAB>\ Primary Endpoint: Molecular genetic testing Secondary Endpo [...]

  2. Minor

    48 amendments

    48 re-verifications since 2025-06-17, no change to tracked fields

    v340-v387

  3. Minor

    Eligibility criteria expanded, about 234 words

    Secondary endpoints revised (4); Study description expanded, about 7 words

    Show what changed: Eligibility criteria
    INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following criteria: Stated willingness to comply with all study procedures and availability for the duration of the study. Male or female, aged 3 years to 70 yearswith: Evidence for the existence of a tumor of the hypothalamic-pituitary unit or related disorder, as indicated by previously obtained imaging studies or biochemical investigation of the hypothalamohypophysealhypothalamo-hypophyseal function. (aged 2 years to 70 years) or Family members (any age) of patients with a family his [...] [...]
    Show what changed: Secondary endpoints
    [...] iation with other conditions in the families of the patients,. toTo collect peripheral blood DNA samples and tumor tissues and examine the molecular genetic [...]
    Show what changed: Study description
    [...] ectives:<TAB> Primary Objective: To collect peripheral blood DNA samples and tumor tissues and examine the molecular genetic [...] hicle for the development of more related clinical studies. To collect biospecimens. To evaluate the cognitive, psychological, and patient-report [...] alth status of mental and social well-being and symptoms of hypercortisolemia and adrenal insufficiency (AI) associated with recovery from Cushing syndrome (CS) in children with this disease. Endpoints: <TAB> Primary Endpoint: Molecular genetic testing, whole exome sequencing Secondary Endpoints: Pre- and/or post- treatment compa [...] [...]

    Study Status, Study Description, Outcome Measures, Eligibilityv339

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 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.
Trial Details
NCT Number NCT00001595
Lead Sponsor Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions Panhypopituitarism, Gigantism/Acromegaly, Prolactinoma, Cushing Disease
Enrollment 2,000 participants
Start Date
Updated on ClinicalTrials.gov