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

NCT01066338 | Unknown DMC

• 1 other identifier: 2009-10-070
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Myeloid Leukemia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• overall response rate

  within 1 month after enrollment

Secondary Outcomes (1)

• overall survival time

  within 1 month after enrollment

Study Arms (1)

Normal karyotype

The patients were diagnosed as acute myeloid leukemia with normal karyotype.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patients who were diagnosed as acute myeloid leukemia with normal karyotype will be enrolled.

You may qualify if:

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

You may not qualify if:

• no definitive criteria

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The stored bone marrow specimens of patients with normal karyotype AML who were treated with chemotherapy

MeSH Terms

Conditions

Leukemia, Myeloid; Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Dong Hwan Kim, M.D.,Ph.D.

  Division of Hematology and Oncology/Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong Hwan Kim, M.D.,Ph.D.

CONTACT

+82-2-3410-1768; dr.dennis.kim@samsung.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 8, 2010
• First Posted: February 10, 2010
• Study Start: February 1, 2010
• Last Updated: February 19, 2010

Record last verified: 2010-02

Locations

KR (1)