Acute Lymphoblastic Leukemia, Pediatric, Adverse Drug Event
Conditions
Keywords
adverse drug event, acute lymphoblastic leukemia, mercaptopurine, pharmacogenomics
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.
Interventions
None listed
Sponsors
Stanford University
Cipherome, Inc.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 21 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Pediatric ALL subjects who did NOT receive 6-mercaptopurine * No biobank sample * No WBC level
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed