Pharmacogenomics of Asparaginase Induced Hepatotoxicity
NCT ID: NCT03568266
Last Updated: 2025-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
500 participants
OBSERVATIONAL
2018-05-22
2026-12-31
Brief Summary
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Detailed Description
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I. To establish the association between the SOD2 rs4880 genotypes and asparaginase-induced hepatotoxicity in Hispanic patients.
II. To identify novel single nucleotide polymorphisms (SNPs) that are associated with asparaginase induced hepatotoxicity.
OUTLINE:
Participants' 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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Biospecimen Collection
Buccal swabs of prospective participants' saliva will be collected when participant achieves complete remission (during regular clinical visit) from their asparaginase treatment.
Biospecimen Collection
Undergo collection of saliva
Interventions
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Biospecimen Collection
Undergo collection of saliva
Eligibility Criteria
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Inclusion Criteria
* Receiving asparaginase as part of the primary treatment regimen
* Ability to understand and the willingness to sign a written informed consent
* For retrospective recruitment, those who have received asparaginase between 2012 and 2017; and are current patients of University of Southern California (USC)
Exclusion Criteria
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Southern California
OTHER
Responsible Party
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Principal Investigators
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Houda Alachkar, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NCI-2018-00813
Identifier Type: REGISTRY
Identifier Source: secondary_id
9L-17-16
Identifier Type: OTHER
Identifier Source: secondary_id
9L-17-16
Identifier Type: -
Identifier Source: org_study_id
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