Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-31 @ 11:13 AM
Study NCT ID:
NCT00003793
Status:
COMPLETED
Last Update Posted:
2014-08-05
First Post:
1999-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Genetic Study of Children With Soft Tissue Sarcoma or Rhabdomyosarcoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Netherlands', 'New Zealand', 'Puerto Rico', 'Switzerland']}, 'conditionBrowseModule': {'meshes': [{'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}, {'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D012516', 'term': 'Osteosarcoma'}, {'id': 'D005354', 'term': 'Fibrosarcoma'}, {'id': 'D018241', 'term': 'Neuroectodermal Tumors, Primitive, Peripheral'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D018213', 'term': 'Neoplasms, Bone Tissue'}, {'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018218', 'term': 'Neoplasms, Fibrous Tissue'}, {'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': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 294}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-04', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2014-08-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Event Free Survival'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['secondary acute myeloid leukemia', 'secondary myelodysplastic syndromes', 'localized osteosarcoma', 'metastatic osteosarcoma', 'childhood soft tissue sarcoma', 'nonmetastatic childhood soft tissue sarcoma', 'metastatic childhood soft tissue sarcoma', 'childhood fibrosarcoma', 'childhood synovial sarcoma', 'childhood neurofibrosarcoma', 'previously untreated childhood rhabdomyosarcoma', 'localized Ewing sarcoma/peripheral primitive neuroectodermal tumor', 'metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor'], 'conditions': ['Leukemia', 'Myelodysplastic Syndromes', 'Sarcoma']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Determination of genetic markers for soft tissue sarcoma or rhabdomyosarcoma may help doctors identify patients who are at risk for therapy-related leukemia.\n\nPURPOSE: Clinical trial to study genetic testing of children with soft tissue sarcoma or rhabdomyosarcoma to identify children who are at risk of developing leukemia from the chemotherapy used to treat sarcoma.', 'detailedDescription': 'OBJECTIVES:\n\n* Identify genetically susceptible patients to therapy-induced myelodysplastic syndrome or acute myelogenous leukemia (t-MDS/AML) prior to initiation of high-dose chemotherapy for sarcoma.\n* Identify patients who are at increased risk of t-MDS/AML during or after therapy.\n\nOUTLINE: Blood is collected from patients at diagnosis (preferably before chemotherapy or transfusion), at end of therapy, and at 6 months, 1 year, 2 years, and 3 years after therapy.\n\nBlood specimens are examined by clonality analysis (HUMARA), variant cell frequency (glycophorin A assay), GST NAT2/CYP1A1 genotyping, microsatellite instability, and ras mutation detection (single strand conformation polymorphism and sequencing of mutant alleles).\n\nPatients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment.\n\nPROJECTED ACCRUAL: A total of 321 patients will be accrued for this study within 4 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children receiving high dose chemotherapy for sarcomas.', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Diagnosis of sarcoma including:\n\n * Rhabdomyosarcoma\n * Ewing's sarcoma\n * Primitive neuroectodermal tumor\n * Fibrosarcoma\n * Malignant peripheral nerve sheath tumor\n * Synovial cell sarcoma\n * Osteosarcoma\n * Other soft tissue sarcoma\n* Must be currently receiving intensive or high-dose chemotherapy for sarcoma\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* Children\n\nPerformance status:\n\n* Not specified\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Not specified\n\nHepatic:\n\n* Not specified\n\nRenal:\n\n* Not specified\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* See Disease Characteristics\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* Not specified\n\nSurgery\n\n* Not specified"}, 'identificationModule': {'nctId': 'NCT00003793', 'briefTitle': 'Genetic Study of Children With Soft Tissue Sarcoma or Rhabdomyosarcoma', 'organization': {'class': 'NETWORK', 'fullName': "Children's Oncology Group"}, 'officialTitle': 'Clinical and Biological Predictors of Therapy-Related Leukemia', 'orgStudyIdInfo': {'id': 'AB9804'}, 'secondaryIdInfos': [{'id': 'COG-AB9804', 'type': 'OTHER', 'domain': "Children's Oncology Group"}, {'id': 'CCG-B9804', 'type': 'OTHER', 'domain': "Children's Cancer Group"}, {'id': 'CDR0000066936', 'type': 'OTHER', 'domain': 'Clinical Trials.gov'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Identification of Genetical suceptibility prior to therapy', 'description': 'Determine the glutathione-s-transferase theta (GSTT1) or glutathione-s-transferase mu (GSTM1) null genotype is more frequent in individuals with t-MDS/AML. Determine the GSTT1 or GSTM1 null genotype is associated with a reduced incidence of relapse of sarcoma. Determine NAT2 or CYP1A1 genotype influences risk of t-MDS/AML. Determine development of a "mutator phenotype" as demonstrated by developing microsatellite instability is an early marker of individuals likely to progress to t-MDS/AML.', 'interventionNames': ['Genetic: microsatellite instability analysis', 'Genetic: mutation analysis']}, {'label': 'Increased Risk Of T-MDS/AML before/after Therapy', 'description': 'Determine clonal hematopoiesis develops in children receiving high intensity alkylating agent chemotherapy for sarcomas. Determine development of clonal hematopoiesis is associated with increased frequency of t-MDS/AML. Determine measurement of somatic cell mutation frequency, measured by the glycophorin A (GPA) assay prior to and after chemotherapy will predict individuals at increased risk of t-MDS/AML. Identify individuals with ras gene mutations in normal peripheral blood cells after therapy, and whether the identification of such mutations is associated with increased risk of t-MDS/AML blood cells after therapy, and whether the identification of such mutations is associated with increased risk of t-MDS/AML.', 'interventionNames': ['Genetic: clonality analysis', 'Genetic: microsatellite instability analysis', 'Genetic: mutation analysis']}], 'interventions': [{'name': 'clonality analysis', 'type': 'GENETIC', 'armGroupLabels': ['Increased Risk Of T-MDS/AML before/after Therapy']}, {'name': 'microsatellite instability analysis', 'type': 'GENETIC', 'armGroupLabels': ['Identification of Genetical suceptibility prior to therapy', 'Increased Risk Of T-MDS/AML before/after Therapy']}, {'name': 'mutation analysis', 'type': 'GENETIC', 'armGroupLabels': ['Identification of Genetical suceptibility prior to therapy', 'Increased Risk Of T-MDS/AML before/after Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90242', 'city': 'Downey', 'state': 'California', 'country': 'United States', 'facility': 'Southern California Permanente Medical Group', 'geoPoint': {'lat': 33.94001, 'lon': -118.13257}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': "Jonathan Jaques Children's Cancer Center at Miller Children's Hospital", 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90095-1781', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Jonsson Comprehensive Cancer Center at UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '93638', 'city': 'Madera', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital Central California", 'geoPoint': {'lat': 36.96134, 'lon': -120.06072}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Comprehensive Cancer Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Comprehensive Cancer Center at Stanford University Medical Center', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '06360-2875', 'city': 'Farmington', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center', 'geoPoint': {'lat': 41.71982, 'lon': -72.83204}}, {'zip': '19899', 'city': 'Wilmington', 'state': 'Delaware', 'country': 'United States', 'facility': 'Alfred I. duPont Hospital for Children', 'geoPoint': {'lat': 39.74595, 'lon': -75.54659}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Lombardi Comprehensive Cancer Center at Georgetown University Medical Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'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': '33901', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Lee Cancer Care of Lee Memorial Health System', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '32610-0232', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida Shands Cancer Center', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '32207-8482', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': "Nemours Children's Clinic", 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33155', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': "Miami Children's Hospital", 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33176-2197', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Baptist-South Miami Regional Cancer Program', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32803-1273', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Hospital Cancer Institute at Florida Hospital Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33701', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': "All Children's Hospital", 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '33607', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': "St. Joseph's Cancer Institute at St. Joseph's Hospital", 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33407', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': "Kaplan Cancer Center at St. Mary's Medical Center", 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Winship Cancer Institute of Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '31403-3089', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': 'Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '60614', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Children's Memorial Hospital - Chicago", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '50309', 'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': "Blank Children's Hospital", 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'zip': '40232', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': "Kosair Children's Hospital", 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '70118', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': "Children's Hospital of New Orleans", 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '04401', 'city': 'Bangor', 'state': 'Maine', 'country': 'United States', 'facility': 'CancerCare of Maine at Eastern Maine Medial Center', 'geoPoint': {'lat': 44.79884, 'lon': -68.77265}}, {'zip': '04074', 'city': 'Scarborough', 'state': 'Maine', 'country': 'United States', 'facility': "Maine Children's Cancer Program", 'geoPoint': {'lat': 43.57814, 'lon': -70.32172}}, {'zip': '48109-0286', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': "C.S. Mott Children's Hospital at University of Michigan", 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48201-1379', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Barbara Ann Karmanos Cancer Institute', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48503', 'city': 'Flint', 'state': 'Michigan', 'country': 'United States', 'facility': 'Hurley Medical Center', 'geoPoint': {'lat': 43.01253, 'lon': -83.68746}}, {'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'Spectrum Health Hospital - Butterworth Campus', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '48236', 'city': 'Grosse Pointe Woods', 'state': 'Michigan', 'country': 'United States', 'facility': 'Van Elslander Cancer Center at St. John Hospital and Medical Center', 'geoPoint': {'lat': 42.44365, 'lon': -82.90686}}, {'zip': '49007-3731', 'city': 'Kalamazoo', 'state': 'Michigan', 'country': 'United States', 'facility': 'CCOP - Kalamazoo', 'geoPoint': {'lat': 42.29171, 'lon': -85.58723}}, {'zip': '55404', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': "Children's Hospitals and Clinics of Minneapolis", 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': "University of Minnesota Medical Center & Children's Hospital - Fairview", 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic Cancer Center', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '39216-4505', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'University of Mississippi Medical Center', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '65203', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'Ellis Fischel Cancer Center at University of Missouri - 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Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '28232-2861', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Blumenthal Cancer Center at Carolinas Medical Center', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '28233-3549', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Presbyterian Cancer Center at Presbyterian Hospital', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27157-1096', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University Comprehensive Cancer Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '58122', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': 'CCOP - MeritCare Hospital', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}, {'zip': '44308-1062', 'city': 'Akron', 'state': 'Ohio', 'country': 'United States', 'facility': "Children's Hospital Medical Center of Akron", 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}, {'zip': '45229-3039', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Taussig Cancer Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43205-2696', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Columbus Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '45404-1815', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': "Children's Medical Center - Dayton", 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '44501', 'city': 'Youngstown', 'state': 'Ohio', 'country': 'United States', 'facility': "Tod Children's Hospital - Forum Health", 'geoPoint': {'lat': 41.09978, 'lon': -80.64952}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Oklahoma University Medical Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '97227', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Institute of Oncology at Vilnius University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '17033-0850', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State Cancer Institute at Milton S. 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