ID

45224

Beschrijving

Principal Investigator: Mary V. Relling, PharmD, St. Jude Children's Research Hospital, Memphis, TN USA MeSH: Acute Lymphoblastic Leukemia https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000426 Methotrexate plasma concentration is related to its clinical effects. To identify the genetic basis of interindividual variability in methotrexate pharmacokinetics in children with newly diagnosed acute lymphoblastic leukemia (ALL), we performed a genome-wide analysis (GWAS) of 500,568 germline single-nucleotide polymorphisms (SNPs) in 434 children with ALL who received 3,014 courses of methotrexate at 2 to 5 g/m2. SNPs were validated in an independent cohort of 206 patients. Adjusting for age, race, sex, and methotrexate regimen, the most significant associations were with SNPs in the organic anion transporter polypeptide, *SLCO1B1* (rs11045879 (P = 1.7 x 10sup-10/sup) and rs4149081 (P = 1.7 x 10sup-9/sup) (Trevino et al, PMID: 19901119). To test whether rare variants in *SLCO1B1* could alter its function, we genotyped *SLCO1B1* exons in a slightly larger group of 699 children with ALL who received methotrexate and identified 93 single nucleotide polymorphisms (SNPs). We found several common and rare non-synonymous (NS) SNPs associated with methotrexate clearance. NS SNPs predicted to be functionally damaging (common or rare) were more likely to be found among patients with the lowest adjusted methotrexate clearance (lowest 10%) than patients with high clearance (highest 10%). Four *SLCO1B1* haplotypes were associated with reduced methotrexate clearance and we verified that these haplotypes have lower function with in vitro transport assays. We were able to quantitatively account for a third of the population variability in clearance of methotrexate with clinical and genetic covariates. This data set includes the dependent variable of methotrexate clearance and all of the SNP data available from arrays, sequencing, and genotyping.

Link

dbGaP study = phs000426

Trefwoorden

  1. 29-07-22 29-07-22 - Simon Heim
  2. 12-10-22 12-10-22 - Adrian Schulz
Houder van rechten

Mary V. Relling, PharmD, St. Jude Children's Research Hospital, Memphis, TN USA

Geüploaded op

12 oktober 2022

DOI

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Licentie

Creative Commons BY 4.0

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dbGaP phs000426 SLCO1B1 Variants and Methotrexate Clearance

Eligibility Criteria

Inclusion and exclusion criteria
Beschrijving

Inclusion and exclusion criteria

Participant has a confirmed diagnosis of non-B-cell acute lymphoblastic leukemia (ALL)
Beschrijving

Participant has a confirmed diagnosis of non-B-cell acute lymphoblastic leukemia (ALL)

Datatype

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0023492
UMLS CUI [1,3]
C0023449
Participant is less than or equal to 18 years of age
Beschrijving

Participant is less than or equal to 18 years of age

Datatype

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0001779
Written, informed consent following NCI, IRB, FDA, and OPRR Guidelines
Beschrijving

Written, informed consent following NCI, IRB, FDA, and OPRR Guidelines

Datatype

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0021430
Patient received high-dose methotrexate as part of protocol-directed therapy for ALL
Beschrijving

Patient received high-dose methotrexate as part of protocol-directed therapy for ALL

Datatype

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0444956
UMLS CUI [1,4]
C0025677

Similar models

Eligibility Criteria

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Inclusion and exclusion criteria
Participant has a confirmed diagnosis of non-B-cell acute lymphoblastic leukemia (ALL)
Item
Participant has a confirmed diagnosis of non-B-cell acute lymphoblastic leukemia (ALL)
boolean
C1512693 (UMLS CUI [1,1])
C0023492 (UMLS CUI [1,2])
C0023449 (UMLS CUI [1,3])
Participant is less than or equal to 18 years of age
Item
Participant is less than or equal to 18 years of age
boolean
C1512693 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
Written, informed consent following NCI, IRB, FDA, and OPRR Guidelines
Item
Written, informed consent following NCI, IRB, FDA, and OPRR Guidelines
boolean
C1512693 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
Patient received high-dose methotrexate as part of protocol-directed therapy for ALL
Item
Patient received high-dose methotrexate as part of protocol-directed therapy for ALL
boolean
C1512693 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0444956 (UMLS CUI [1,3])
C0025677 (UMLS CUI [1,4])

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