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dbGaP phs000638 Genome-Wide Association Study of Relapse of Childhood Acute Lymphoblastic Leukemia - Eligibility

- 25/11/22 - 5 moduli, 1 ItemGroup, 1 elemento, 1 linguaggio
ItemGroup: IG.elig
Principal Investigator: Mary V. Relling, PharmD, St. Jude Children Research Hospital, Memphis, TN, USA MeSH: Precursor Cell Lymphoblastic Leukemia-Lymphoma https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000638 Using risk-directed therapy for childhood acute lymphoblastic leukemia (ALL), outcome has improved dramatically in the last 40 years. However, a substantial portion of patients experience relapse, many of whom have no known risk factors. Taking a genome-wide approach, we sought to evaluate the relationships between germline SNP genotypes and the risk of relapse in 2,535 children with newly diagnosed ALL after adjusting for genetic ancestry and treatment regimen. We examine prognostic value of selected SNPs in the context of known relapse risk factors (molecular subtypes, minimal residual disease, age and leukocyte count at diagnosis). Associations of relapse-related SNPs with pharmacokinetic and pharmacodynamics of antileukemic drugs offer plausible mechanism by which they are linked to treatment outcome. Finally, we aim to identify SNPs that are related to both genetic ancestry and relapse which are likely to contribute to racial disparities in ALL survival.

pht003568.v1.p1

1 ItemGroup 4 elementi

pht003571.v1.p1

1 ItemGroup 5 elementi

pht003569.v1.p1

1 ItemGroup 5 elementi

pht003570.v1.p1

1 ItemGroup 5 elementi

dbGaP phs000426 SLCO1B1 Variants and Methotrexate Clearance - pht002452.v1.p1

- 12/10/22 - 5 moduli, 1 ItemGroup, 2 elementi, 1 linguaggio
ItemGroup: pht002452
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.

Eligibility

1 ItemGroup 4 elementi

pht002453.v1.p1

1 ItemGroup 2 elementi

pht002454.v1.p1

1 ItemGroup 3 elementi

pht002455.v1.p1

1 ItemGroup 5 elementi

dbGaP phs000341 The Genetic Basis of Hypodiploid ALL - pht002673.v2.p1

- 12/10/22 - 6 moduli, 1 ItemGroup, 5 elementi, 1 linguaggio
ItemGroup: pht002673
Principal Investigator: Charles Mullighan, MBBS(Hons), MSc, MD, Dept. of Pathology, St. Jude Children's Research Hospital, Memphis, TN, USA MeSH: Precursor Cell Lymphoblastic Leukemia-Lymphoma https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000341 The genetic basis of hypodiploid acute lymphoblastic leukemia (ALL), a subtype of ALL characterized by aneuploidy and poor outcome, is unknown. Genomic profiling of 124 hypodiploid ALL cases, including whole-genome and exome sequencing of 40 cases, identified two subtypes that differ in the severity of aneuploidy, transcriptional profiles and submicroscopic genetic alterations. Near-haploid ALL with 24-31 chromosomes harbor alterations targeting receptor tyrosine kinase signaling and Ras signaling (71%) and the lymphoid transcription factor gene IKZF3 (encoding AIOLOS; 13%). In contrast, low-hypodiploid ALL with 32-39 chromosomes are characterized by alterations in TP53 (91.2%) that are commonly present in nontumor cells, IKZF2 (encoding HELIOS; 53%) and RB1 (41%). Both near-haploid and low-hypodiploid leukemic cells show activation of Ras-signaling and phosphoinositide 3-kinase (PI3K)-signaling pathways and are sensitive to PI3K inhibitors, indicating that these drugs should be explored as a new therapeutic strategy for this aggressive form of leukemia.

pht002675.v2.p1

1 ItemGroup 6 elementi

pht003165.v1.p1

1 ItemGroup 15 elementi

pht003171.v1.p1

1 ItemGroup 2 elementi

pht002672.v2.p1

1 ItemGroup 5 elementi

Eligibility

1 ItemGroup 1 elemento

Eligibility Leukemia, Lymphocytic NCT00313079

- 20/09/21 - 1 modulo, 2 itemgroups, 35 elementi, 1 linguaggio
Itemgroups: Inclusion Criteria, Exclusion Criteria
Monoclonal Antibody (mAb) 216 With Chemotherapy in Adult Relapsed or Refractory B-Lineage Acute Lymphoblastic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00313079

Eligibility Philadelphia Positive Acute Lymphoblastic Leukemia NCT00199186

- 31/07/17 - 1 modulo, 2 itemgroups, 16 elementi, 1 linguaggio
Itemgroups: Inclusion Criteria, Exclusion Criteria
Study Comparing Imatinib With Chemotherapy as Induction in Elderly Patients With Philadelphia Positive Acute Lymphoblastic Leukemia (ALL); ODM derived from: https://clinicaltrials.gov/show/NCT00199186

Eligibility Lymphoblastic Leukemia NCT00866749

- 14/05/17 - 1 modulo, 2 itemgroups, 14 elementi, 1 linguaggio
Itemgroups: Inclusion Criteria, Exclusion Criteria
Augmented Berlin-Frankfurt-Munster (BFM) Therapy for Adolescent/Young Adults With Acute Lymphoblastic Leukemia or Acute Lymphoblastic Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00866749

Eligibility Precursor Cell Lymphoblastic Leukemia-Lymphoma NCT02428517

- 14/06/16 - 1 modulo, 2 itemgroups, 18 elementi, 1 linguaggio
Itemgroups: Inclusion Criteria, Exclusion Criteria
Allogeneic Hematopoietic Cell Transplantation for Adult Acute Lymphoblastic Leukemia (2015); ODM derived from: https://clinicaltrials.gov/show/NCT02428517

Eligibility Adult T Acute Lymphoblastic Leukemia NCT00408005

- 22/04/16 - 1 modulo, 2 itemgroups, 15 elementi, 1 linguaggio
Itemgroups: Inclusion Criteria, Exclusion Criteria
Combination Chemotherapy in Treating Young Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00408005

Eligibility Adult Acute Lymphocytic Leukemia NCT00199108

- 16/04/16 - 1 modulo, 2 itemgroups, 13 elementi, 1 linguaggio
Itemgroups: Inclusion Criteria, Exclusion Criteria
Treatment of Acute Lymphoblastic Leukemia or Aggressive Lymphoma With Relapse in Central Nervous System With Depocyt; ODM derived from: https://clinicaltrials.gov/show/NCT00199108

Eligibility Adult Acute Lymphoblastic Leukemia in Remission NCT00039377

- 16/04/16 - 1 modulo, 1 ItemGroup, 8 elementi, 1 linguaggio
ItemGroup: Inclusion Criteria
Chemotherapy, Imatinib Mesylate, and Peripheral Stem Cell Transplantation in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00039377

Eligibility Adult Acute Lymphocytic Leukemia NCT00198978

- 16/04/16 - 1 modulo, 2 itemgroups, 17 elementi, 1 linguaggio
Itemgroups: Inclusion Criteria, Exclusion Criteria
German Multicenter Trial for Treatment of Elderly Patients With Newly Diagnosed Acute Lymphoblastic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00198978

Eligibility Leukemia NCT00005596

- 19/01/16 - 1 modulo, 1 ItemGroup, 6 elementi, 1 linguaggio
ItemGroup: Criteria
Combination Chemotherapy in Treating Children With Newly Diagnosed Acute Lymphoblastic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00005596

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