Pharmacogenomics of Asparaginase Induced Hepatotoxicity
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|ClinicalTrials.gov Identifier: NCT03568266|
Recruitment Status : Recruiting
First Posted : June 25, 2018
Last Update Posted : May 2, 2019
|Condition or disease||Intervention/treatment|
|Acute Lymphoblastic Leukemia||Procedure: Biospecimen Collection|
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.
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.
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||Pharmacogenomics of Age-Specific, Asparaginase-Induced Hepatotoxicity in Patients With Acute Lymphoblastic Leukemia|
|Actual Study Start Date :||May 22, 2018|
|Estimated Primary Completion Date :||May 22, 2024|
|Estimated Study Completion Date :||May 22, 2025|
Buccal swabs of prospective participants' saliva will be collected when participant achieves complete remission (during regular clinical visit) from their asparaginase treatment.
Procedure: Biospecimen Collection
Undergo collection of saliva
- Hepatotoxicity following treatment with asparaginase [ Time Frame: Up to 6 months ]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.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03568266
|Contact: Christine Duran||323-865-0371||Duran_C@med.usc.edu|
|United States, California|
|USC / Norris Comprehensive Cancer Center||Recruiting|
|Los Angeles, California, United States, 90033|
|Contact: Houda Alachkar, PhD 323-442-2696 firstname.lastname@example.org|
|Principal Investigator: Houda Alachkar, PhD|
|Principal Investigator:||Houda Alachkar, Ph.D.||University of Southern California|