Genome-wide Pharmacogenetic Candidate Gene Single Nucleotide Polymorphism (SNP) Array-based Approach to Predict Chemoresponse and Survival in Patients With Acute Myeloid Leukemia With Normal Karyotype

Sponsor

Samsung Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT01066338

Collaborator

(none)

500

Enrollment

Location

Study Details

Study Description

Brief Summary

The most reliable prognostic marker of acute myeloid leukemia(AML) is cytogenetics by karyotyping. According to cytogenetic results, the patients with AML are classified as better, intermediate and poor prognosis groups. The normal karyotype AML was reported in about 50% of all AML and classified as intermediate risk group. However, the patients with normal karyotype AML showed various prognosis. Therefore, the further studies about subgroup analysis of normal karyotype AML are needed. Recently, the understandings of human genome polypmorphism using SNP array have been accumulated. However, the advanced researches for clinical application are not enough.

The study design is a retrospective and single-center study. The patients with normal karyotyping AML who were diagnosed from 1994 to 2008 at Samsung Medical Center (South Korea) will be enrolled. The stored bone marrow samples of enrolled patients are used for genome wide scanning by SNP array.

The purpose of present study is to develop predictive pharmacogenemic biomarkers model associated wit clinical outcomes including efficacy and toxicity in patients with AML with normal karyotype treated with chemotherapy using pharmacogenetic SNP array. And secondly, to develop enrichment clinical trial based on predictive pharmacogenomic model.

Condition or Disease	Intervention/Treatment	Phase
Myeloid Leukemia

Study Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

Genome-wide Pharmacogenetic Candidate Gene SNP Array-based Approach to Predict Chemoresponse and Survival in Patients With Acute Myeloid Leukemia With Normal Karyotype

Study Start Date :

Feb 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Normal karyotype The patients were diagnosed as acute myeloid leukemia with normal karyotype.

Outcome Measures

Primary Outcome Measures

overall response rate [within 1 month after enrollment]

Secondary Outcome Measures

overall survival time [within 1 month after enrollment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

patients with normal karyotype acute myeloid leukemia
18 years or older
patients were treated with standard chemotherapy
patients with available medical record and stored bone marrow specimen at time of diagnosis