Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2026-02-23 @ 6:27 AM
Study NCT ID:
NCT01623856
Status:
COMPLETED
Last Update Posted:
2015-05-07
First Post:
2012-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Studying Genes Associated With Non-Hodgkin Lymphoma in Young Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002051', 'term': 'Burkitt Lymphoma'}], 'ancestors': [{'id': 'D020031', 'term': 'Epstein-Barr Virus Infections'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 483}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-06', 'studyFirstSubmitDate': '2012-06-15', 'studyFirstSubmitQcDate': '2012-06-17', 'lastUpdatePostDateStruct': {'date': '2015-05-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Potential deviations from Hardy-Weinberg Equilibrium (HWE)', 'timeFrame': 'Baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Childhood Burkitt Lymphoma', 'Childhood Lymphoblastic Lymphoma']}, 'descriptionModule': {'briefSummary': 'This research studies genes associated with non-Hodgkin lymphoma in young patients. Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer', 'detailedDescription': 'OBJECTIVES:\n\nI. To conduct a preliminary investigation of the effects of loci strongly and consistently associated in prior genome-wide association studies (GWAS) and validation studies of childhood/adolescent acute lymphoblastic leukemia (ALL), adult non-Hodgkin lymphoma (NHL), autoimmune diseases, and atopic diseases on the risk of NHL (lymphoblastic and Burkitt lymphomas) in children and adolescents.\n\nOUTLINE:\n\nDNA samples are analyzed by single nucleotide polymorphism and genotyped by fluorogenic polymerase chain reaction (PCR)-based allelic discrimination (Taqman) assays using the ABI Prism 7900HT reverse transcriptase (RT)-PCR system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with lymphoblastic lymphoma (LL) or Burkitt lymphoma ( BL) enrolled on the Children Oncology Group (COG) protocols 5961, A5971, or ANHL01P1.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Slides and/or other available specimens from patients diagnosed with lymphoblastic lymphoma (LL) or Burkitt lymphoma ( BL) enrolled on the Children Oncology Group (COG) protocols 5961, A5971, and ANHL01P1 collected at the time of diagnosis and currently housed at the Biopathology Center at Nationwide Children's Hospital\n\n * Samples from non-Hispanic white patients\n* DNA samples from 384 healthy, anonymous, non-Hispanic white blood donors used as controls\n* See Disease Characteristics\n* Not specified"}, 'identificationModule': {'nctId': 'NCT01623856', 'briefTitle': 'Studying Genes Associated With Non-Hodgkin Lymphoma in Young Patients', 'organization': {'class': 'NETWORK', 'fullName': "Children's Oncology Group"}, 'officialTitle': 'Observational - Candidate Gene Variants and Childhood/Adolescent Non-Hodgkin Lymphoma: A Preliminary Investigation', 'orgStudyIdInfo': {'id': 'ANHL12B1'}, 'secondaryIdInfos': [{'id': 'NCI-2012-01975', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational', 'description': 'DNA samples are analyzed by single nucleotide polymorphism and genotyped by fluorogenic polymerase chain reaction (PCR)-based allelic discrimination (Taqman) assays using the ABI Prism 7900HT reverse transcriptase (RT)-PCR system.', 'interventionNames': ['Other: laboratory biomarker analysis']}], 'interventions': [{'name': 'laboratory biomarker analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Observational']}]}, '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': 'Amy Linabery, 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'}}}}