Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2026-01-01 @ 2:45 PM
Study NCT ID:
NCT00588068
Status:
RECRUITING
Last Update Posted:
2025-10-15
First Post:
2007-12-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Molecular Characterization of Neuroblastic Tumor: Correlation With Clinical Outcome
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': 'D047368', 'term': 'Tumor Burden'}], 'ancestors': [{'id': 'D001837', 'term': 'Body Weights and Measures'}, {'id': 'D000886', 'term': 'Anthropometry'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Tumor, marrow and blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2070}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2000-09-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-13', 'studyFirstSubmitDate': '2007-12-24', 'studyFirstSubmitQcDate': '2008-01-07', 'lastUpdatePostDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To study the molecular-genetic makeup and metastasis of neuroblastic tumors.', 'timeFrame': '2 years', 'description': 'Before surgery a maximum of 5 blood drawings (20-30 ml) will be performed per year (at least one month apart) per patient'}], 'secondaryOutcomes': [{'measure': 'To study the correlation of these biologic markers with clinical outcome.', 'timeFrame': '2 years', 'description': 'Before surgery and a maximum of 5 blood drawings (20-30 ml) will be performed per year (at least one month apart) per patient'}, {'measure': 'To relate neuroblastic tumor and embryonic neuroectodermal cell circuitry.', 'timeFrame': '2 years', 'description': 'Up to six fetal adrenal samples will be obtained (without patient identifiers) from gestational week 20, when neuroblasts are present and thought to be differentiating within the fetal adrenal gland.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Adrenal Gland', 'No stage requirement'], 'conditions': ['Neuroblastoma']}, 'referencesModule': {'references': [{'pmid': '34550633', 'type': 'DERIVED', 'citation': 'Felix CA, Slater DJ, Davenport JW, Yu X, Gregory BD, Li MM, Rappaport EF, Cheung NV. KMT2A-MAML2 rearrangement emerged and regressed during neuroblastoma therapy without leukemia after 12.8-year follow-up. Pediatr Blood Cancer. 2022 Jan;69(1):e29344. doi: 10.1002/pbc.29344. Epub 2021 Sep 22.'}, {'pmid': '22416102', 'type': 'DERIVED', 'citation': "Cheung NK, Zhang J, Lu C, Parker M, Bahrami A, Tickoo SK, Heguy A, Pappo AS, Federico S, Dalton J, Cheung IY, Ding L, Fulton R, Wang J, Chen X, Becksfort J, Wu J, Billups CA, Ellison D, Mardis ER, Wilson RK, Downing JR, Dyer MA; St Jude Children's Research Hospital-Washington University Pediatric Cancer Genome Project. Association of age at diagnosis and genetic mutations in patients with neuroblastoma. JAMA. 2012 Mar 14;307(10):1062-71. doi: 10.1001/jama.2012.228."}], 'seeAlsoLinks': [{'url': 'http://www.mskcc.org', 'label': 'Memorial Sloan Kettering Cancer Center website'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to find out the genetic and biochemical makeup of your neuroblastic tumor, which influences its aggressiveness and the suitable therapy. These research studies include surface marker analysis, cytogenetics, cancer genes,genome sequencing, tumor growth-related genes and tumor growth in test tubes. Your blood, marrow, and hematopoietic stem cell samples will also be tested for tumors or leukemia cells, and your serum tested for anti-tumor antibodies.', 'detailedDescription': 'To collect tumor, marrow specimens prospectively to study the molecular-genetic makeup of individual neuroblastic tumor and its metastasis by blood and marrow, and to correlate these findings with clinical outcome, and to relate the signaling circuitry of neuroblastic tumors to that of embryonic neuroectodermal cells. .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients will be offered participation in this study by their attending oncologist in the Department of Pediatrics at Memorial Sloan Kettering Cancer Center.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Neuroblastic tumors diagnosed in accordance with the International Neuroblastoma Staging System\n\nOR\n\n* Clinically suspected neuroblastic tumors.\n\nPK DRAW INCLUSION CRITERIA (FOR PK DRAWS ONLY):\n\nPK Draw Inclusion Criteria\n\n* Patients who receive naxitamab as part of their standard of care\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT00588068', 'briefTitle': 'Molecular Characterization of Neuroblastic Tumor: Correlation With Clinical Outcome', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'Molecular Characterization of Neuroblastic Tumor: Correlation With Clinical Outcome', 'orgStudyIdInfo': {'id': '00-109'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Tumor and Marrow Markers', 'interventionNames': ['Other: Tumor and Marrow Markers']}], 'interventions': [{'name': 'Tumor and Marrow Markers', 'type': 'OTHER', 'description': 'Tumor and Marrow Markers', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nai-Kong Cheung, M.D., Ph.D.', 'role': 'CONTACT'}, {'name': 'Nai-Kong Cheung, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Nai-Kong Cheung, M.D., Ph.D.', 'role': 'CONTACT', 'phone': '646-888-2313'}, {'name': 'Shakeel Modak, MD', 'role': 'CONTACT', 'phone': '212-639-7623'}], 'overallOfficials': [{'name': 'Nai-Kong Cheung, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Southern Illinois University', 'class': 'OTHER'}, {'name': 'Spanish National Cancer Center', 'class': 'UNKNOWN'}, {'name': "St. Jude Children's Research Hospital", 'class': 'OTHER'}, {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, {'name': 'University of Texas', 'class': 'OTHER'}, {'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}