- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00897858
Studying Cerebrospinal Fluid Proteins and Angiogenesis Proteins in Young Patients With Newly Diagnosed Central Nervous System Tumors
Evaluation of Cerebral Spinal Fluid (CSF) Proteome and Angiogenesis Proteins in Children With Newly Diagnosed Central Nervous System Tumors
RATIONALE: Studying samples of cerebrospinal fluid from patients with cancer in the laboratory may help doctors identify biomarkers related to cancer.
PURPOSE: This laboratory study is studying cerebrospinal fluid proteins and angiogenesis proteins in young patients with newly diagnosed central nervous system tumors.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
OBJECTIVES:
Primary
- Investigate the feasibility of centrally collecting and processing high-quality cerebrospinal fluid (CSF) samples from pediatric patients with newly diagnosed central nervous system tumors for proteomic studies.
- Identify protein markers that might indicate the presence of a brain tumor using CSF samples collected from these patients.
OUTLINE: This is a multicenter study.
Patients undergo cerebrospinal fluid (CSF) collection from any or all of the following 5 sites: lumbar, cervical, ommaya, intra-operative (ventricular, cisternal), and/or external ventricular drain. CSF is obtained within 8 weeks of diagnosis but prior to (or concurrent with) the initiation of any post-operative therapy (excluding corticosteroids).
CSF samples are examined for proteomic biomarkers by 2D gel electrophoresis, low-mass fingerprinting, and stable isotope labeling.
PROJECTED ACCRUAL: A total of 99 patients will be accrued for this study.
Type d'étude
Contacts et emplacements
Lieux d'étude
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District of Columbia
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Washington, District of Columbia, États-Unis, 20010-2970
- Children's National Medical Center
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Illinois
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Chicago, Illinois, États-Unis, 60614
- Children's Memorial Hospital - Chicago
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Massachusetts
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Boston, Massachusetts, États-Unis, 02115
- Dana-Farber Cancer Institute
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North Carolina
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Durham, North Carolina, États-Unis, 27710
- Duke Comprehensive Cancer Center
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Pennsylvania
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Philadelphia, Pennsylvania, États-Unis, 19104-4318
- Children's Hospital of Philadelphia
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Pittsburgh, Pennsylvania, États-Unis, 15213
- Children's Hospital of Pittsburgh
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Texas
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Houston, Texas, États-Unis, 77030-2399
- Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital
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Washington
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Seattle, Washington, États-Unis, 98105
- Children's Hospital and Regional Medical Center - Seattle
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
DISEASE CHARACTERISTICS:
Histologically confirmed CNS tumors of any of the following histologies:
- Diffuse pontine gliomas*
Focal/infiltrative tumors, including any of the following:
- High- and low-grade gliomas
- Gangliogliomas
- Ependymomas
- Oligodendrogliomas
- Craniopharyngioma
- Dysembryoplastic neuroepithelial tumors
- Other low-grade neoplasms
- Optic pathway gliomas*
Seeding tumors, including any of the following:
- Germ cell tumors (germinomas and nongerminomas)
Embryonal tumors, including any of the following:
- Medulloblastoma
- Pineoblastoma
- Supratentorial primitive neuroectodermal tumors
- Atypical teratoid/rhabdoid tumor
- Other embryonal tumors NOTE: *Histological requirement waived
- Newly diagnosed disease
- Cerebrospinal fluid (CSF) obtained as part of CSF diversion, initial diagnosis/staging, or administration of intrathecal chemotherapy (at the initiation of postoperative therapy)
PATIENT CHARACTERISTICS:
- Less than 22 years of age
PRIOR CONCURRENT THERAPY:
- No prior radiotherapy or chemotherapy
- Prior corticosteroids allowed
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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Pediatric CNS tumor patients
Newly diagnosed pediatric patients with CNS tumor and no prior irradiation or chemotherapy
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Number of IRB approvals of the study
Délai: Within 120 days of study release
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IRB approval will be used as a surrogate marker of support for this protocol.
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Within 120 days of study release
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Number of patients with proteomic data received at the Operations and Biostatistics Center
Délai: 12, 18, 24, and 30 months after 4th IRB approval
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Feasibility implies registering patients, submitting samples for proteomic investigation, and successfully analyzing the data at the lab in a timely fashion.
The number of patients with proteomic data received at the PBTC Operations and Biostatistics Center will be assessed at 12, 18, 24, and 30 months after the 4th institution receives IRB approval for the study.
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12, 18, 24, and 30 months after 4th IRB approval
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Number of differentially expressed biomarker proteins
Délai: Pre-treatment
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Unsupervised proteomic profiling will be done on the CSF samples obtained pre-treatment in order to identify proteins that differ between pediatric brain tumor patients and a banked set of pediatric control "normal" samples.
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Pre-treatment
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chaise d'étude: Brian R. Rood, MD, Children's National Research Institute
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
- gliome du tronc cérébral infantile non traité
- astrocytome cérébral de haut grade chez l'enfant
- médulloblastome infantile non traité
- astrocytome cérébelleux infantile non traité
- épendymome sous-tentoriel de l'enfant
- épendymome infantile nouvellement diagnostiqué
- tumeur tératoïde/rhabdoïde atypique de l'enfant
- épendymome supratentoriel de l'enfant
- craniopharyngiome infantile
- tumeur germinale du système nerveux central de l'enfant
- tumeur du plexus choroïde chez l'enfant
- méningiome de grade I de l'enfance
- méningiome de grade II de l'enfant
- méningiome de grade III chez l'enfant
- astrocytome cérébral de bas grade chez l'enfant
- tumeur neuroectodermique primitive supratentorielle de l'enfant non traitée
- voie visuelle infantile non traitée et gliome hypothalamique
- gliome des voies visuelles de l'enfant non traité
- choriocarcinome du système nerveux central de l'enfant
- tumeur embryonnaire du système nerveux central de l'enfant
- germinome du système nerveux central de l'enfant
- tumeur germinale mixte du système nerveux central de l'enfant
- tératome du système nerveux central de l'enfant
- tumeur du sac vitellin du système nerveux central de l'enfant
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CDR0000481330
- PBTC-N08 (Autre identifiant: Pediatric Brain Tumor Consortium)
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