Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-25 @ 5:36 PM
Study NCT ID:
NCT01358604
Status:
COMPLETED
Last Update Posted:
2016-04-15
First Post:
2011-05-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Biomarkers in Samples From Young Patients With Neuroblastoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009447', 'term': 'Neuroblastoma'}], 'ancestors': [{'id': 'D018241', 'term': 'Neuroectodermal Tumors, Primitive, Peripheral'}, {'id': 'D018242', 'term': 'Neuroectodermal Tumors, Primitive'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016133', 'term': 'Polymerase Chain Reaction'}, {'id': 'D015153', 'term': 'Blotting, Western'}, {'id': 'D005434', 'term': 'Flow Cytometry'}, {'id': 'D007150', 'term': 'Immunohistochemistry'}], 'ancestors': [{'id': 'D021141', 'term': 'Nucleic Acid Amplification Techniques'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D004586', 'term': 'Electrophoresis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D055664', 'term': 'Electrochemical Techniques'}, {'id': 'D015151', 'term': 'Immunoblotting'}, {'id': 'D007118', 'term': 'Immunoassay'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D015336', 'term': 'Molecular Probe Techniques'}, {'id': 'D002469', 'term': 'Cell Separation'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003592', 'term': 'Cytophotometry'}, {'id': 'D005470', 'term': 'Fluorometry'}, {'id': 'D008163', 'term': 'Luminescent Measurements'}, {'id': 'D010783', 'term': 'Photometry'}, {'id': 'D006651', 'term': 'Histocytochemistry'}, {'id': 'D006652', 'term': 'Histological Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-14', 'studyFirstSubmitDate': '2011-05-18', 'studyFirstSubmitQcDate': '2011-05-18', 'lastUpdatePostDateStruct': {'date': '2016-04-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ROR1 is expressed on the surface of neuroblastoma cells and constitutes a suitable target for mAb therapy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['localized resectable neuroblastoma', 'recurrent neuroblastoma', 'regional neuroblastoma', 'stage 4S neuroblastoma', 'localized unresectable neuroblastoma'], 'conditions': ['Neuroblastoma']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Studying samples of tissue and bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.\n\nPURPOSE: This research study studies biomarkers in samples from young patients with neuroblastoma.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* To analyze the expression of ROR1 on the surface of primary neuroblastoma cells.\n* To investigate the therapeutic potential of anti-ROR1 monoclonal antibodies (mAbs), bispecific antibodies, and immunotoxins in in vitro and in vivo models of neuroblastoma.\n\nOUTLINE: Archived bone marrow and tumor tissue samples are analyzed for ROR1 expression by flow cytometry, western blotting, qPCR, and IHC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with neuroblastoma.', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosed with neuroblastoma\n\n * With or without N-myc amplification\n* Primary tumor samples as frozen tissue in liquid nitrogen or -80 degrees C\n* Bone marrow samples from high-risk patients as peripheral blood mononuclear cells (PBMC) that have been cryopreserved with DMSO as viable cells to be used for flow cytometry or slides of bone marrow that can be used for immunohistochemistry\n\nPATIENT CHARACTERISTICS:\n\n* Not specified\n\nPRIOR CONCURRENT THERAPY:\n\n* Not specified'}, 'identificationModule': {'nctId': 'NCT01358604', 'briefTitle': 'Biomarkers in Samples From Young Patients With Neuroblastoma', 'organization': {'class': 'NETWORK', 'fullName': "Children's Oncology Group"}, 'officialTitle': 'ROR1 as a Novel Target for Neuroblastoma', 'orgStudyIdInfo': {'id': 'ANBL11B2'}, 'secondaryIdInfos': [{'id': 'COG-ANBL11B2', 'type': 'OTHER', 'domain': "Children's Oncology Group"}, {'id': 'NCI-2011-02855', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'ANBL11B2', 'type': 'OTHER', 'domain': "Children's Oncology Group"}]}, 'armsInterventionsModule': {'interventions': [{'name': 'polymerase chain reaction', 'type': 'GENETIC'}, {'name': 'protein expression analysis', 'type': 'GENETIC'}, {'name': 'western blotting', 'type': 'GENETIC'}, {'name': 'flow cytometry', 'type': 'OTHER'}, {'name': 'immunohistochemistry staining method', 'type': 'OTHER'}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'David Hema, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NCI - Experimental Transplantation and Immunology Branch'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Oncology Group", 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}