Pharmacogenomic Analysis in Pediatric Acute Lymphoblastic Leukemia
- Conditions
- Acute Lymphoblastic Leukemia, PediatricAdverse Drug Event
- Registration Number
- NCT04770922
- Lead Sponsor
- Cipherome, Inc.
- Brief Summary
This is a retrospective biobank study evaluating the impact of novel genetic variants in a population of 6-mercaptopurine treated pediatric acute lymphoblastic leukemia patients.
- Detailed Description
The study objective is to clinically validate that the presence of recently discovered novel genetic variation adversely affects a population of 6-mercaptopurine treated pediatric acute lymphoblastic leukemia patients using biobank samples.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- Pediatric acute lymphoblastic leukemia (ALL) subjects
- Received 6-mercaptopurine
- Available biobank (bone marrow or blood) sample(s) from which deoxyribonucleic acid (DNA) can be extracted
- White blood cell (WBC) levels
- Pediatric ALL subjects who did NOT receive 6-mercaptopurine
- No biobank sample
- No WBC level
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Novel genetic variants impact on 6-mercaptopurine adverse drug reactions 1 year Objective is to clinically validate the presence of novel genetic variants and its impact on adverse drug reactions in a population of pediatric ALL patients treated with 6-MP
- Secondary Outcome Measures
Name Time Method Evaluating relationship of genetic variants to ancestry 1 year A secondary objective of this study is to compare the impact of the novel genetic variants with other known genetic variants contributing to ADR risk.
Trial Locations
- Locations (1)
Stanford University
🇺🇸Stanford, California, United States
Stanford University🇺🇸Stanford, California, United States