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
Recruitment status was Recruiting
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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 |
- overall response rate [ Time Frame: within 1 month after enrollment ] [ Designated as safety issue: No ]
- 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 |
The patients who were diagnosed as acute myeloid leukemia with normal karyotype will be enrolled.
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| Contact: Dong Hwan Kim, M.D.,Ph.D. | +82-2-3410-1768 | dr.dennis.kim@samsung.com |
| 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 | |
| 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, Acute Leukemia, Myeloid Neoplasms by Histologic Type Neoplasms |
ClinicalTrials.gov processed this record on June 17, 2013