ClinicalTrials.gov
ClinicalTrials.gov Menu

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 safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01066338
Recruitment Status : Unknown
Verified February 2010 by Samsung Medical Center.
Recruitment status was:  Recruiting
First Posted : February 10, 2010
Last Update Posted : February 19, 2010
Sponsor:
Information provided by:
Samsung Medical Center

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
Myeloid Leukemia

Study Type : Observational
Estimated 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 : February 2010


Group/Cohort
Normal karyotype
The patients were diagnosed as acute myeloid leukemia with normal karyotype.



Primary Outcome Measures :
  1. overall response rate [ Time Frame: within 1 month after enrollment ]

Secondary Outcome Measures :
  1. overall survival time [ Time Frame: within 1 month after enrollment ]

Biospecimen Retention:   Samples With DNA
The stored bone marrow specimens of patients with normal karyotype AML who were treated with chemotherapy


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: February 10, 2010    Key Record Dates
Last Update Posted: February 19, 2010
Last Verified: February 2010

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 by Histologic Type
Neoplasms