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

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:
NCT01066286
First received: February 8, 2010
Last updated: February 9, 2010
Last verified: February 2010
  Purpose

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 extraction/storage of tumor cell DNAs from marrow samples, then processing of Affymetrix SNP array 6.0.
  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, FLT3/ITD, 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, FLT3/ITD 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.

Condition
Myeloid Leukemia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
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

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

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

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

Biospecimen Retention:   Samples With DNA

Stored bone marrow specimens of patient with core binding factor positive acute myeloid leukemia treated with chemotherapy between 1995 and 2008 at Samsung Medical Center and Hwasun Chonnam National University Hospital


Estimated Enrollment: 100
Study Start Date: February 2010
Groups/Cohorts
core binding factor positive
core binding factor positive acute myeloid leukemia

  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

core binding factor positive acute myeloid leukemia

Criteria

Inclusion Criteria:

  • patients with core binding factor positive 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 definive 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: NCT01066286

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   
Principal Investigator: Dong Hwan Kim, M.D.,Ph.D.         
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: NCT01066286     History of Changes
Other Study ID Numbers: 2009-10-069
Study First Received: February 8, 2010
Last Updated: February 9, 2010
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
genome wide SNP-array
micro-cytogenetic lesion
KIT mutation
core binding factor
acute myeloid leukemia
The Approval status was changed from Pending to Approved.

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

ClinicalTrials.gov processed this record on August 01, 2014