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

NCT01066286 | Unknown DMC

• 1 other identifier: 2009-10-069
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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. 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. 2.Construction of prognostic predictive model using pharmacogenomics with the results of genotypes and copy number variations (CNVs).
3. 3.Detection of hidden microscopic cytogenetic lesions with SNP array technique, and correlation with clinical outcomes in CBF positive AML.
4. 4.Detection of KIT, FLT3/ITD, and NPM1 gene mutation and its correlation with clinical outcomes in CBF positive AML.
5. 5.To detect microcytogenetic lesions and will analyze its prognostic significance
6. 6.To analyze genome-wide genotypes and copy number variations (CNVs) using pharmacogenetic approach and will construct a prognostic predictive model
7. 7.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.

Conditions

Myeloid Leukemia

Keywords

genome wide SNP-array; micro-cytogenetic lesion; KIT mutation; core binding factor; acute myeloid leukemia; The Approval status was changed from Pending to Approved.

Outcome Measures

Primary Outcomes (1)

• response rate

  within 1 month after enrollment

Secondary Outcomes (1)

• overall survival and progression-free survival

  within 1 month after enrollment

Study Arms (1)

core binding factor positive

core binding factor positive acute myeloid leukemia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

core binding factor positive acute myeloid leukemia

You may qualify if:

• patients with core binding factor positive acute myeloid leukemia
• years or older
• patients were treated with standard chemotherapy
• patients with available medical record and stored bone marrow specimen at time of diagnosis

You may not qualify if:

• no definive criteria

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

RECRUITING

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

MeSH Terms

Conditions

Leukemia, Myeloid; Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Dong Hwan Kim, M.D.,Ph.D.

  Division of Hematology and Oncology/Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong Hwan Kim, M.D.,Ph.D.

CONTACT

+82-2-3410-1768; dr.dennis.kim@samsung.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 8, 2010
• First Posted: February 10, 2010
• Study Start: February 1, 2010
• Last Updated: February 10, 2010

Record last verified: 2010-02

Locations

KR (1)