Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:11 PM
Study NCT ID:
NCT00897858
Status:
WITHDRAWN
Last Update Posted:
2013-04-19
First Post:
2009-05-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Studying Cerebrospinal Fluid Proteins and Angiogenesis Proteins in Young Patients With Newly Diagnosed Central Nervous System Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D016545', 'term': 'Choroid Plexus Neoplasms'}, {'id': 'D018335', 'term': 'Rhabdoid Tumor'}, {'id': 'D001254', 'term': 'Astrocytoma'}], 'ancestors': [{'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D002551', 'term': 'Cerebral Ventricle Neoplasms'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D018193', 'term': 'Neoplasms, Complex and Mixed'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D005910', 'term': 'Glioma'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': "This non-therapeutic study was registered in error. The PRS team doesn't delete studies once registered, so they recommended changing the status to Withdrawn", 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'lastUpdateSubmitDate': '2013-04-18', 'studyFirstSubmitDate': '2009-05-09', 'studyFirstSubmitQcDate': '2009-05-09', 'lastUpdatePostDateStruct': {'date': '2013-04-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of IRB approvals of the study', 'timeFrame': 'Within 120 days of study release', 'description': 'IRB approval will be used as a surrogate marker of support for this protocol.'}, {'measure': 'Number of patients with proteomic data received at the Operations and Biostatistics Center', 'timeFrame': '12, 18, 24, and 30 months after 4th IRB approval', 'description': '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.'}, {'measure': 'Number of differentially expressed biomarker proteins', 'timeFrame': 'Pre-treatment', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['childhood central nervous system germ cell tumor', 'childhood choroid plexus tumor', 'childhood grade I meningioma', 'childhood grade II meningioma', 'childhood grade III meningioma', 'childhood atypical teratoid/rhabdoid tumor', 'untreated childhood visual pathway glioma', 'childhood infratentorial ependymoma', 'childhood supratentorial ependymoma', 'newly diagnosed childhood ependymoma', 'childhood craniopharyngioma', 'untreated childhood medulloblastoma', 'untreated childhood cerebellar astrocytoma', 'untreated childhood supratentorial primitive neuroectodermal tumor', 'untreated childhood brain stem glioma', 'untreated childhood visual pathway and hypothalamic glioma', 'childhood high-grade cerebral astrocytoma', 'childhood low-grade cerebral astrocytoma', 'childhood central nervous system choriocarcinoma', 'childhood central nervous system embryonal tumor', 'childhood central nervous system germinoma', 'childhood central nervous system mixed germ cell tumor', 'childhood central nervous system teratoma', 'childhood central nervous system yolk sac tumor'], 'conditions': ['Brain and Central Nervous System Tumors']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Studying samples of cerebrospinal fluid from patients with cancer in the laboratory may help doctors identify biomarkers related to cancer.\n\nPURPOSE: This laboratory study is studying cerebrospinal fluid proteins and angiogenesis proteins in young patients with newly diagnosed central nervous system tumors.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* 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.\n* Identify protein markers that might indicate the presence of a brain tumor using CSF samples collected from these patients.\n\nOUTLINE: This is a multicenter study.\n\nPatients 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).\n\nCSF samples are examined for proteomic biomarkers by 2D gel electrophoresis, low-mass fingerprinting, and stable isotope labeling.\n\nPROJECTED ACCRUAL: A total of 99 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of newly diagnosed pediatric patients with a CNS tumor and no prior irradiation or chemotherapy. Cerebrospinal fluid (CSF) is withdrawn as part of initial diagnosis/staging, the administration of intrathecal therapy, or CSF diversion.', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed CNS tumors of any of the following histologies:\n\n * Diffuse pontine gliomas\\*\n * Focal/infiltrative tumors, including any of the following:\n\n * High- and low-grade gliomas\n * Gangliogliomas\n * Ependymomas\n * Oligodendrogliomas\n * Craniopharyngioma\n * Dysembryoplastic neuroepithelial tumors\n * Other low-grade neoplasms\n * Optic pathway gliomas\\*\n * Seeding tumors, including any of the following:\n\n * Germ cell tumors (germinomas and nongerminomas)\n * Embryonal tumors, including any of the following:\n\n * Medulloblastoma\n * Pineoblastoma\n * Supratentorial primitive neuroectodermal tumors\n * Atypical teratoid/rhabdoid tumor\n * Other embryonal tumors NOTE: \\*Histological requirement waived\n* Newly diagnosed disease\n* Cerebrospinal fluid (CSF) obtained as part of CSF diversion, initial diagnosis/staging, or administration of intrathecal chemotherapy (at the initiation of postoperative therapy)\n\nPATIENT CHARACTERISTICS:\n\n* Less than 22 years of age\n\nPRIOR CONCURRENT THERAPY:\n\n* No prior radiotherapy or chemotherapy\n* Prior corticosteroids allowed'}, 'identificationModule': {'nctId': 'NCT00897858', 'briefTitle': 'Studying Cerebrospinal Fluid Proteins and Angiogenesis Proteins in Young Patients With Newly Diagnosed Central Nervous System Tumors', 'organization': {'class': 'NETWORK', 'fullName': 'Pediatric Brain Tumor Consortium'}, 'officialTitle': 'Evaluation of Cerebral Spinal Fluid (CSF) Proteome and Angiogenesis Proteins in Children With Newly Diagnosed Central Nervous System Tumors', 'orgStudyIdInfo': {'id': 'CDR0000481330'}, 'secondaryIdInfos': [{'id': 'PBTC-N08', 'type': 'OTHER', 'domain': 'Pediatric Brain Tumor Consortium'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pediatric CNS tumor patients', 'description': 'Newly diagnosed pediatric patients with CNS tumor and no prior irradiation or chemotherapy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20010-2970', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': "Children's National Medical Center", 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '60614', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Children's Memorial Hospital - Chicago", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Comprehensive Cancer Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '19104-4318', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Pittsburgh", 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '77030-2399', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Children's Hospital and Regional Medical Center - Seattle", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Brian R. Rood, MD', 'role': 'STUDY_CHAIR', 'affiliation': "Children's National Research Institute"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pediatric Brain Tumor Consortium', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}