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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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01066338
Enrollment
500
Registered
2010-02-10
Start date
2010-02-28
Completion date
Unknown
Last updated
2010-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myeloid Leukemia

Keywords

SNP array, prognosis, acute myeloid leukemia, normal karyotype, acute myeloid leukemia with normal karyotype

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.

Interventions

None listed

Sponsors

Samsung Medical Center
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Exclusion criteria

* no definitive criteria

Design outcomes

Primary

MeasureTime frame
overall response ratewithin 1 month after enrollment

Secondary

MeasureTime frame
overall survival timewithin 1 month after enrollment

Countries

South Korea

Contacts

Primary ContactDong Hwan Kim, M.D.,Ph.D.
dr.dennis.kim@samsung.com+82-2-3410-1768

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026