Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2025-12-25 @ 2:11 PM
Study NCT ID:
NCT03568266
Status:
RECRUITING
Last Update Posted:
2025-12-04
First Post:
2018-06-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacogenomics of Asparaginase Induced Hepatotoxicity
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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Saliva'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-05-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2018-06-14', 'studyFirstSubmitQcDate': '2018-06-14', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hepatotoxicity following treatment with asparaginase', 'timeFrame': 'Up to 6 months', 'description': 'Hepatotoxicity per Common Terminology Criteria for Adverse Events version 4.0 (CTCAE) and defined as \\> or = grade 3 of both aspartate aminotransferase (AST) and alanine aminotransferase (ALT), or \\> or = grade 3 bilirubin elevation.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Lymphoblastic Leukemia']}, 'descriptionModule': {'briefSummary': 'This pilot trial studies the impact of genetic information on developing liver damage caused by asparaginase in participants with newly diagnosed acute lymphoblastic leukemia. Testing saliva samples may help doctors find certain genetic markers that may predict whether participants will tolerate asparaginase, which is given as part of clinical care for acute lymphoblastic leukemia.', 'detailedDescription': "PRIMARY OBJECTIVES:\n\nI. To establish the association between the SOD2 rs4880 genotypes and asparaginase-induced hepatotoxicity in Hispanic patients.\n\nII. To identify novel single nucleotide polymorphisms (SNPs) that are associated with asparaginase induced hepatotoxicity.\n\nOUTLINE:\n\nParticipants' SOD2 rs4880 SNP genotype (based on saliva from buccal swabs) will be classified. Participants with the CC genotype will be compared to participants with the CT or TT genotype. Buccal swabs of prospective participants' saliva will be collected when participant achieves complete remission (during regular clinical visit). Retrospective participants will be identified through search of pharmacy records for those who received asparaginase within the last 5 years (2012-2017). Recurrent patients will be consented during their regular clinical visits and samples will be collected."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Newly diagnosed with Acute Lymphoblastic Leukemia (ALL) who are seen at USC facilities will be recruited.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly diagnosed with acute lymphoblastic leukemia (ALL) - no prior treatment for ALL\n* Receiving asparaginase as part of the primary treatment regimen\n* Ability to understand and the willingness to sign a written informed consent\n* For retrospective recruitment, those who have received asparaginase between 2012 and 2017; and are current patients of University of Southern California (USC)\n\nExclusion Criteria:\n\n* Patients who are unable to give informed consent'}, 'identificationModule': {'nctId': 'NCT03568266', 'briefTitle': 'Pharmacogenomics of Asparaginase Induced Hepatotoxicity', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern California'}, 'officialTitle': 'Pharmacogenomics of Age-Specific, Asparaginase-Induced Hepatotoxicity in Patients With Acute Lymphoblastic Leukemia', 'orgStudyIdInfo': {'id': '9L-17-16'}, 'secondaryIdInfos': [{'id': 'NCI-2018-00813', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '9L-17-16', 'type': 'OTHER', 'domain': 'USC / Norris Comprehensive Cancer Center'}, {'id': 'P30CA014089', 'link': 'https://reporter.nih.gov/quickSearch/P30CA014089', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Biospecimen Collection', 'description': "Buccal swabs of prospective participants' saliva will be collected when participant achieves complete remission (during regular clinical visit) from their asparaginase treatment.", 'interventionNames': ['Procedure: Biospecimen Collection']}], 'interventions': [{'name': 'Biospecimen Collection', 'type': 'PROCEDURE', 'description': 'Undergo collection of saliva', 'armGroupLabels': ['Biospecimen Collection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Houda Alachkar, PhD', 'role': 'CONTACT', 'email': 'alachkar@usc.edu', 'phone': '323-442-2696'}, {'name': 'Houda Alachkar, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'USC / Norris Comprehensive Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'centralContacts': [{'name': 'Christine Duran', 'role': 'CONTACT', 'email': 'Duran_C@med.usc.edu', 'phone': '323-865-0371'}], 'overallOfficials': [{'name': 'Houda Alachkar, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Southern California'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern California', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}