Ignite Creation Date:
2024-05-05 @ 10:25 PM
Last Modification Date:
2024-10-26 @ 10:18 AM
Study NCT ID:
NCT01106144
Status:
UNKNOWN
Last Update Posted:
2011-05-24
First Post:
2010-04-15
Brief Title:
Genetic Predictive Model Based on Single Nucleotide Polymorphisms in the DNA Repair Pathway and Drug MetabolisTransport Pharmacogenetics in the Prediction of Response and Treatment Outcomes in Acute Myeloid Leukemia
Sponsor:
Samsung Medical Center
Organization:
Samsung Medical Center
Study Overview
Official Title:
Genetic Predictive Model Based on Single Nucleotide Polymorphisms in the DNA Repair Pathway and Drug MetabolisTransport Pharmacogenetics in the Prediction of Response and Treatment Outcomes in Acute Myeloid Leukemia
Status:
UNKNOWN
Status Verified Date:
2011-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main component in the treatment of acute myeloid leukemia AML is consist of anthracycline such as daunorubicin or idarubicin and cytarabine Inter-individual variability of transportmetabolism of the chemotherapeutic agent and several genetic pathways involved in the drug action might be associated with different response following the treatment for AML usually consisted of chemotherapy andor transplantation One of potential pathways involved in the drug action is DNA repair pathway accordingly single nucleotide polymorphisms SNPs in the DNA repair machinery pathway might be a predictive marker for therapy outcomes in AML
Several genes were involved in the DNA repair machinery which are 1 Nonhomologous end joining NHEJ pathway involved in the G1S phase 2 Homologous recombinational repair HRR pathway involved in the SG2 phase XRCC4 LIG4 MRN and ATM are well known genes involved in the NHEJ pathway while MRE11 RAD50 NBS1 MRN RAD51 XRCC2 XRCC3 RAD51B RAD51C RAD 51D RAD52 or RAD54 are known to be associated with HRR pathway
A study suggested that the SNPs in the DNA repair pathway was involved in the susceptibility of secondary AML developing after chemotherapy or autologous hematopoietic stem cell transplantation thus these SNP markers could become a predictive marker for secondary AML However it has never been investigated for multiple candidate pathways simultaneously with relateively larger number of patients Accordingly the current study attempts to investigate the potential role of the genotype markers in multiple candidate pathways esp focused on the DNA repair machinery with respect to response following chemotherapy or survival of AML patients
Total of over 500 archived samples from the patients diagnosed as acute myeloid leukemia at the Samsung Medical Center Seoul Korea will be included and genomic DNAs will be extracted and will be examined for their genotypes of the candidate SNPs involved in the DNA repair pathways Then statistical analysis will be pursued for single marker analysis haplotype analysis and for the construction of genetic risk model based on the multivariate analysis
Several genes were involved in the DNA repair machinery which are 1 Nonhomologous end joining NHEJ pathway involved in the G1S phase 2 Homologous recombinational repair HRR pathway involved in the SG2 phase XRCC4 LIG4 MRN and ATM are well known genes involved in the NHEJ pathway while MRE11 RAD50 NBS1 MRN RAD51 XRCC2 XRCC3 RAD51B RAD51C RAD 51D RAD52 or RAD54 are known to be associated with HRR pathway
A study suggested that the SNPs in the DNA repair pathway was involved in the susceptibility of secondary AML developing after chemotherapy or autologous hematopoietic stem cell transplantation thus these SNP markers could become a predictive marker for secondary AML However it has never been investigated for multiple candidate pathways simultaneously with relateively larger number of patients Accordingly the current study attempts to investigate the potential role of the genotype markers in multiple candidate pathways esp focused on the DNA repair machinery with respect to response following chemotherapy or survival of AML patients
Total of over 500 archived samples from the patients diagnosed as acute myeloid leukemia at the Samsung Medical Center Seoul Korea will be included and genomic DNAs will be extracted and will be examined for their genotypes of the candidate SNPs involved in the DNA repair pathways Then statistical analysis will be pursued for single marker analysis haplotype analysis and for the construction of genetic risk model based on the multivariate analysis
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None