Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-29 @ 5:05 AM
Study NCT ID:
NCT00898404
Status:
COMPLETED
Last Update Posted:
2016-05-11
First Post:
2009-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Response or Resistance to Chemotherapy in Young Patients With Acute Lymphoblastic Leukemia Treated With Methotrexate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}], 'ancestors': [{'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-09', 'studyFirstSubmitDate': '2009-05-09', 'studyFirstSubmitQcDate': '2009-05-09', 'lastUpdatePostDateStruct': {'date': '2016-05-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Molecular basis for human reduced folate carrier (hRFC) transcripts', 'timeFrame': 'Up to 4 years'}, {'measure': 'Correlation of hRFC expression and methotrexate transport and sensitivities', 'timeFrame': 'Up to 4 years'}, {'measure': 'High frequency gene/transcript variants for hRFC in relation to response and resistance to methotrexate', 'timeFrame': 'Up to 4 years'}, {'measure': 'Multidrug resistance-associated proteins in relation to response and resistance to methotrexate and mercaptopurine', 'timeFrame': 'Up to 4 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['B-cell Childhood Acute Lymphoblastic Leukemia', 'Childhood Acute Lymphoblastic Leukemia in Remission', 'Recurrent Childhood Acute Lymphoblastic Leukemia', 'T-cell Childhood Acute Lymphoblastic Leukemia']}, 'descriptionModule': {'briefSummary': 'This laboratory study is looking at response or resistance to chemotherapy in young patients with acute lymphoblastic leukemia treated with methotrexate. Studying samples of tumor tissue in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and drug resistance in patients.', 'detailedDescription': "OBJECTIVES:\n\nI. Determine the molecular basis for human reduced folate carrier (hRFC) transcripts in B-precursor and T-cell acute lymphoblastic leukemia (ALL) blasts obtained from children with newly diagnosed ALL subsequently treated with methotrexate.\n\nII. Correlate hRFC expression in these specimens with methotrexate transport and sensitivities.\n\nIII. Determine the roles of high frequency gene/transcript variants for hRFC as determinants of response and resistance to methotrexate in these patients.\n\nIV. Determine the roles of multidrug resistance-associated proteins as determinants of response and resistance to methotrexate and mercaptopurine in these patients.\n\nOUTLINE: This is a multicenter study.\n\nTumor diagnostic specimens from patients who subsequently failed therapy within 4 years of diagnosis or who did not fail therapy within 4 years of diagnosis (control patients) are obtained from the Children's Oncology Group cellbank. Specimens are studied for molecular determinants of human reduced folate carrier (hRFC) gene expression and gene sequence alterations using reverse transcriptase-polymerase chain reaction (RT-PCR), thymidylate synthase inhibition assay, Rnase protection assay, or 5'RACE. Multidrug resistance proteins are also studied by RT-PCR.\n\nA certificate of confidentiality protecting the identity of research participants in this project has been issued by the National Cancer Institute."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Newly Diagnosed Patients with ALL treated with Methotrexate', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of B-precursor or T-cell acute lymphoblastic leukemia\n\n * Newly diagnosed disease subsequently treated with methotrexate\n* Banked diagnostic blast specimens are available from Childrens Oncology Group (COG) cellbank'}, 'identificationModule': {'nctId': 'NCT00898404', 'briefTitle': 'Response or Resistance to Chemotherapy in Young Patients With Acute Lymphoblastic Leukemia Treated With Methotrexate', 'organization': {'class': 'NETWORK', 'fullName': "Children's Oncology Group"}, 'officialTitle': 'Molecular Correlates of Methotrexate in Childhood ALL', 'orgStudyIdInfo': {'id': 'AALL04B1'}, 'secondaryIdInfos': [{'id': 'NCI-2009-00308', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'CDR0000346452', 'type': 'OTHER', 'domain': 'Clinical Trials.gov'}, {'id': 'COG-AALL04B1', 'type': 'OTHER', 'domain': "Children's Oncology Group"}, {'id': 'R01CA076641', 'link': 'https://reporter.nih.gov/quickSearch/R01CA076641', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Arm I', 'description': "Tumor diagnostic specimens from patients who subsequently failed therapy within 4 years of diagnosis or who did not fail therapy within 4 years of diagnosis (control patients) are obtained from the Children's Oncology Group cellbank. Specimens are studied for molecular determinants of human reduced folate carrier (hRFC) gene expression and gene sequence alterations using reverse transcriptase-polymerase chain reaction (RT-PCR), thymidylate synthase inhibition assay, Rnase protection assay, or 5'RACE. Multidrug resistance proteins are also studied by RT-PCR.", 'interventionNames': ['Other: laboratory biomarker analysis']}], 'interventions': [{'name': 'laboratory biomarker analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Arm I']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91006-3776', 'city': 'Arcadia', 'state': 'California', 'country': 'United States', 'facility': "Children's Oncology Group", 'geoPoint': {'lat': 34.13973, 'lon': -118.03534}}], 'overallOfficials': [{'name': 'Larry Matherly', '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'}}}}