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Report for Clinical Trial NCT03568266

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Pharmacogenomics of Age-Specific, Asparaginase-Induced Hepatotoxicity in Patients With Acute Lymphoblastic Leukemia

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.

NCT03568266 Acute Lymphoblastic Leukemia
MeSH:Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid
HPO:Leukemia Lymphoid leukemia

1 Interventions

Name: Biospecimen Collection

Description: Undergo collection of saliva
Type: Procedure
Group Labels: 1

Biospecimen Collection


Primary Outcomes

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.

Measure: Hepatotoxicity following treatment with asparaginase

Time: Up to 6 months

Time Perspective: Prospective

Case-Only


There is one SNP

SNPs


1 rs4880

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.. 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 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 Acute Lymphoblastic Leukemia Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid PRIMARY OBJECTIVES: I. To establish the association between the SOD2 rs4880 genotypes and asparaginase-induced hepatotoxicity in Hispanic patients.

OUTLINE: Participants' SOD2 rs4880 SNP genotype (based on saliva from buccal swabs) will be classified.



HPO Nodes


HPO: