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

NCT ID: NCT01141673

Last Updated: 2011-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Myeloid Leukemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients with confirmed diagnosis of acute myeloid leukemia

Exclusion Criteria

* non
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Medical University WanFang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Taipei Medical University WanFang Hospital

Principal Investigators

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Hsin-Gjin Eugene Liu

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University WanFang Hospital

Locations

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Taipei Medical University - WanFang Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Hsin-Gjin Eugene Liu

Role: CONTACT

[email protected]
886-2-29307930 ext. 2548

Facility Contacts

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Hsin-Gjin Eugene Liu

Role: primary

[email protected]
886-2-29307930 ext. 2548

Other Identifiers

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FLT3-ITD KIT

Identifier Type: -

Identifier Source: org_study_id

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