Ignite Creation Date:
2024-05-05 @ 10:16 PM
Last Modification Date:
2024-10-26 @ 10:16 AM
Study NCT ID:
NCT01066286
Status:
UNKNOWN
Last Update Posted:
2010-02-10
First Post:
2010-02-08
Brief Title:
Genome Wide SNP Array-based Approach to Detect Micro-cytogenetic Lesions and KIT Mutation to Improve Treatment Outcomes in Patients With Core-binding Factor Positive Acute Myeloid Leukemia
Sponsor:
Samsung Medical Center
Organization:
Samsung Medical Center
Study Overview
Official Title:
Genome Wide SNP Array-based Approach to Detect Micro-cytogenetic Lesions and KIT Mutation to Improve Treatment Outcomes in Patients With Core-binding Factor Positive Acute Myeloid Leukemia
Status:
UNKNOWN
Status Verified Date:
2010-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Core binding factor CBF positive acute myeloid leukemia AML consist of 15 of patients in overall AML expected to harbor a favorable prognosis However around a half of cases relapses Accordingly more sophisticated classification in CBF positive AMLs is essential to achieve further improvement in the treatment outcome The current study is designed to evaluate CBF positive AML patients with genome-wide SNP array and KIT mutation study in CBF positive AML patients diagnosed at the Samsung Medical Center and Hwasun Chonnam National University Hospital Korea between 1994 and 2008
1 Construction of the CBF positive AML patient cohort clinical database establishment including treatment outcomes and prognosis and extractionstorage of tumor cell DNAs from marrow samples then processing of Affymetrix SNP array 60
2 Construction of prognostic predictive model using pharmacogenomics with the results of genotypes and copy number variations CNVs
3 Detection of hidden microscopic cytogenetic lesions with SNP array technique and correlation with clinical outcomes in CBF positive AML
4 Detection of KIT FLT3ITD and NPM1 gene mutation and its correlation with clinical outcomes in CBF positive AML
The current study attempts to analyze genetic data of core binding factor CBF positive acute myeloid leukemia AML using genome wide SNP array technique with tumor DNAs collected at the time of diagnosis
1 To detect microcytogenetic lesions and will analyze its prognostic significance
2 To analyze genome-wide genotypes and copy number variations CNVs using pharmacogenetic approach and will construct a prognostic predictive model
3 To detect KIT FLT3ITD and NPM1 mutation and evaluate its prognostic significance The present study will establish individualized therapy for CBF positive AML will provide a basis for molecular marker guided clinical trial in CBF positive AML
1 Construction of the CBF positive AML patient cohort clinical database establishment including treatment outcomes and prognosis and extractionstorage of tumor cell DNAs from marrow samples then processing of Affymetrix SNP array 60
2 Construction of prognostic predictive model using pharmacogenomics with the results of genotypes and copy number variations CNVs
3 Detection of hidden microscopic cytogenetic lesions with SNP array technique and correlation with clinical outcomes in CBF positive AML
4 Detection of KIT FLT3ITD and NPM1 gene mutation and its correlation with clinical outcomes in CBF positive AML
The current study attempts to analyze genetic data of core binding factor CBF positive acute myeloid leukemia AML using genome wide SNP array technique with tumor DNAs collected at the time of diagnosis
1 To detect microcytogenetic lesions and will analyze its prognostic significance
2 To analyze genome-wide genotypes and copy number variations CNVs using pharmacogenetic approach and will construct a prognostic predictive model
3 To detect KIT FLT3ITD and NPM1 mutation and evaluate its prognostic significance The present study will establish individualized therapy for CBF positive AML will provide a basis for molecular marker guided clinical trial in CBF positive AML
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None