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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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Samsung Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01066338
First received: February 8, 2010
Last updated: February 17, 2010
Last verified: February 2010
  Purpose

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
Myeloid Leukemia

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • overall response rate [ Time Frame: within 1 month after enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • overall survival time [ Time Frame: within 1 month after enrollment ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

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


Estimated Enrollment: 500
Study Start Date: February 2010
Groups/Cohorts
Normal karyotype
The patients were diagnosed as acute myeloid leukemia with normal karyotype.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01066338

Contacts
Contact: Dong Hwan Kim, M.D.,Ph.D. +82-2-3410-1768 dr.dennis.kim@samsung.com

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Dong Hwan Kim, M.D., Ph. D.    +82-2-3410-1768    dr.dennis.kim@samsung.com   
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Dong Hwan Kim, M.D.,Ph.D. Division of Hematology and Oncology/Samsung Medical Center
  More Information

No publications provided

Responsible Party: Dong Hwan (Dennis) Kim/Assistant professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01066338     History of Changes
Other Study ID Numbers: 2009-10-070
Study First Received: February 8, 2010
Last Updated: February 17, 2010
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
SNP array
prognosis
acute myeloid leukemia
normal karyotype
acute myeloid leukemia with normal karyotype

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on November 25, 2014