RecruitingRecruiting
Pharmacogenomics of Asparaginase Induced Hepatotoxicity
NCT03568266 · University of Southern California
In plain English
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Official title
Pharmacogenomics of Age-Specific, Asparaginase-Induced Hepatotoxicity in Patients With Acute Lymphoblastic Leukemia
About this study
PRIMARY OBJECTIVES:
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.
Eligibility criteria
Inclusion Criteria:
* Newly diagnosed with acute lymphoblastic leukemia (ALL) - no prior treatment for ALL
* 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:
* Patients who are unable to give informed consent
Study design
Enrollment target: 500 participants
Age groups: adult, older_adult
Timeline
Starts: 2018-05-22
Estimated completion: 2027-12-31
Last updated: 2026-06-01
Interventions
Procedure: Biospecimen Collection
Primary outcomes
- • Hepatotoxicity following treatment with asparaginase (Up to 6 months)
Sponsor
University of Southern California · other
With: National Cancer Institute (NCI)
Contacts & investigators
ContactChristine Duran · contact · Duran_C@med.usc.edu · 323-865-0371
InvestigatorHouda Alachkar, Ph.D. · principal_investigator, University of Southern California
All locations (2)
Los Angeles General Medical CenterRecruiting
Los Angeles, California, United States
USC / Norris Comprehensive Cancer CenterRecruiting
Los Angeles, California, United States