Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2026-01-02 @ 12:50 PM
Study NCT ID:
NCT01876303
Status:
COMPLETED
Last Update Posted:
2016-07-14
First Post:
2013-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Genetic Biomarkers in Saliva Samples From Patients With Ewing Sarcoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018241', 'term': 'Neuroectodermal Tumors, Primitive, Peripheral'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'saliva'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'FAMILY_BASED'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1650}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'lastUpdateSubmitDate': '2016-07-13', 'studyFirstSubmitDate': '2013-06-10', 'studyFirstSubmitQcDate': '2013-06-11', 'lastUpdatePostDateStruct': {'date': '2016-07-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Main effect of gene polymorphisms', 'timeFrame': 'Up to 5 years', 'description': 'Risk ratios (RR) for the main effect of gene polymorphisms will be calculated using log-linear models. RRs and 95% confidence intervals for the gene-environment interaction are calculated by stratifying the likelihood according to case exposure.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor (PNET)']}, 'referencesModule': {'references': [{'pmid': '36589413', 'type': 'DERIVED', 'citation': 'Zieger HK, Weinhold L, Schmidt A, Holtgrewe M, Juranek SA, Siewert A, Scheer AB, Thieme F, Mangold E, Ishorst N, Brand FU, Welzenbach J, Beule D, Paeschke K, Krawitz PM, Ludwig KU. Prioritization of non-coding elements involved in non-syndromic cleft lip with/without cleft palate through genome-wide analysis of de novo mutations. HGG Adv. 2022 Dec 5;4(1):100166. doi: 10.1016/j.xhgg.2022.100166. eCollection 2023 Jan 12.'}]}, 'descriptionModule': {'briefSummary': 'This clinical trial studies genetic biomarkers from saliva samples in patients with Ewing sarcoma. Studying samples of saliva from patients with cancer in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer.', 'detailedDescription': "PRIMARY OBJECTIVES:\n\nI. To determine the association between the length of Ewing sarcoma breakpoint region 1-Friend leukemia virus integration 1 (EWS-FLI1) fusion protein binding sites (microsatellites) and risk of Ewing's sarcoma (ES).\n\nII. To determine the frequency and commonality of Caucasian ancestral markers in cases of ES self-identified as non-Caucasian (African-American, Asian, Hispanic).\n\nIII. To determine the association between genomic variants in ES-related genes and hernia development (i.e. the integrin signaling pathway) and risk of ES.\n\nOUTLINE:\n\nGenomic DNA is extracted from participants' saliva samples and analyzed for expression of EWS-FLI1 and other ES-target genes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a diagnosis of Ewing Sarcoma meeting other criteria.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The patient is enrolled on ACCRN07\n* The patient has a diagnosis of Ewing Sarcoma (International Classification of Diseases \\[ICD\\] code morphology 9260; topography C40.0-C41.9, C76.0-C76.8, C80.9) and is registered with Children's Oncology Group (COG) by a North American member institution\n* The patient must be diagnosed with Ewing sarcoma between December 24, 2007 and December 31, 2015\n* The patient must have at least one biological parent alive and willing to participate\n* All questionnaire respondents must understand English or Spanish\n* Concomitant treatment on a therapeutic trial is not required"}, 'identificationModule': {'nctId': 'NCT01876303', 'briefTitle': 'Genetic Biomarkers in Saliva Samples From Patients With Ewing Sarcoma', 'organization': {'class': 'NETWORK', 'fullName': "Children's Oncology Group"}, 'officialTitle': "Genetic Epidemiology of Ewing's Sarcoma", 'orgStudyIdInfo': {'id': 'AEPI10N5'}, 'secondaryIdInfos': [{'id': 'NCI-2012-02210', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'AEPI10N5', 'type': 'OTHER', 'domain': "Children's Oncology Group"}, {'id': 'AEPI10N5', 'type': 'OTHER', 'domain': 'CTEP'}, {'id': 'U10CA098543', 'link': 'https://reporter.nih.gov/quickSearch/U10CA098543', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ancillary-Correlative (genetic epidemiology of Ewing sarcoma)', 'description': "Genomic DNA is extracted from participants' saliva samples and analyzed for expression of EWS-FLI1 and other ES-target genes.", 'interventionNames': ['Other: laboratory biomarker analysis', 'Other: questionnaire administration']}], 'interventions': [{'name': 'laboratory biomarker analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Ancillary-Correlative (genetic epidemiology of Ewing sarcoma)']}, {'name': 'questionnaire administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Ancillary-Correlative (genetic epidemiology of Ewing sarcoma)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91006-3776', 'city': 'Monrovia', 'state': 'California', 'country': 'United States', 'facility': "Children's Oncology Group", 'geoPoint': {'lat': 34.14806, 'lon': -117.99895}}], 'overallOfficials': [{'name': 'Joshua Schiffman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Oncology Group"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Oncology Group", 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}