Development of a Diagnostic Kit for FLT3-ITD in Acute Myeloid Leukemia

Sponsor
Taipei Medical University WanFang Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01141673
Collaborator
(none)
100
1
12
8.3

Study Details

Study Description

Brief Summary

FLT3 overexpression in acute myeloid leukemia (AML) is often caused by mutations in this gene. These mutations cause constitutive phosphorylation of FLT3 proteins leading to increased proliferation and survival, decreased apoptosis and resistance to chemotherapeutic agents in AML cells. There are two major types of FLT3 mutations- internal tandem duplication (ITD) and point mutation at 835th amino residue. AMLs with FLT3 mutations have worse prognosis and are often resistant to conventional chemotherapy. Several small molecule compounds targeting FLT3 have been in the market or in clinical trials. Therefore, identification of these mutations at the time of diagnosis will provide a better prognostic prediction, might guide the treatment selection and follow-up strategies. In this study, the investigators will develop a sensitive molecular assay to detect FLT3 mutations for future clinical application. The investigators will collect 100 AML samples with at least 20 samples with known FLT3 mutations. The investigators will compare this assay with commonly used methods and standardize the procedure to meet the requirement of clinical pathology laboratory with reasonable cost.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Development of a Diagnostic Kit for FLT3-ITD in Acute Myeloid Leukemia
    Study Start Date :
    Jun 1, 2010
    Anticipated Study Completion Date :
    Jun 1, 2011

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      N/A and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:
      • Patients with confirmed diagnosis of acute myeloid leukemia
      Exclusion Criteria:
      • non

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Taipei Medical University - WanFang Hospital Taipei Taiwan

      Sponsors and Collaborators

      • Taipei Medical University WanFang Hospital

      Investigators

      • Principal Investigator: Hsin-Gjin Eugene Liu, Taipei Medical University WanFang Hospital

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT01141673
      Other Study ID Numbers:
      • FLT3-ITD KIT
      First Posted:
      Jun 10, 2010
      Last Update Posted:
      Apr 26, 2011
      Last Verified:
      Apr 1, 2011
      Keywords provided by , ,
      Additional relevant MeSH terms:

      Study Results

      No Results Posted as of Apr 26, 2011