Genetic Predictive Model Based on Single Nucleotide Polymorphisms in the DNA Repair Pathway and Drug Metabolis/Transport Pharmacogenetics in the Prediction of Response and Treatment Outcomes in Acute Myeloid Leukemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Samsung Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01106144
First received: April 15, 2010
Last updated: May 23, 2011
Last verified: May 2011

April 15, 2010
May 23, 2011
May 2010
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Complete list of historical versions of study NCT01106144 on ClinicalTrials.gov Archive Site
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Genetic Predictive Model Based on Single Nucleotide Polymorphisms in the DNA Repair Pathway and Drug Metabolis/Transport Pharmacogenetics in the Prediction of Response and Treatment Outcomes in Acute Myeloid Leukemia
Genetic Predictive Model Based on Single Nucleotide Polymorphisms in the DNA Repair Pathway and Drug Metabolis/Transport Pharmacogenetics in the Prediction of Response and Treatment Outcomes in Acute Myeloid Leukemia

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 transport/metabolism 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 and/or 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 G1/S phase, 2) Homologous recombinational repair (HRR) pathway involved in the S/G2 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.

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Observational
Observational Model: Case-Only
Time Perspective: Retrospective
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Retention:   Samples With DNA
Description:

Preserved bone marrow sample from the adult patients with acute myeloid leukemia

Probability Sample

Adult patients with acute myeloid leukemia receiving induction/consolidation combination chemotherapy at Samsung Medical Center from 1996 to 2005

  • Patients With Acute Myeloid Leukemia
  • Patients Receiving Induction/Consolidation Chemotherapy
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Acute myeloid leukemia
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
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Inclusion Criteria:

  • patients with acute myeloid leukemia
  • 15 years or older
  • patients treated with induction/consolidation chemotherapy
  • patients with available bone marrow sample

Exclusion Criteria:

  • acute biphenotypic leukemia
Both
15 Years and older
No
Contact: Dong Hwan Kim, M.D., Ph.D. 82-2-3410-1768 drkiim@medimail.co.kr
Korea, Republic of
 
NCT01106144
2008-08-094
Yes
Dong Hwan Kim, Division of Hematology and Oncology/Samsung Medical Center/Sungkyunkwan University
Samsung Medical Center
Not Provided
Principal Investigator: Dong Hwan Kim, M.D., Ph.D. Samsung Medical Center
Samsung Medical Center
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP