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

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ClinicalTrials.gov Identifier: NCT01141673
Recruitment Status : Unknown
Verified April 2011 by Taipei Medical University WanFang Hospital.
Recruitment status was:  Recruiting
First Posted : June 10, 2010
Last Update Posted : April 26, 2011
Sponsor:
Information provided by:
Taipei Medical University WanFang Hospital

Tracking Information
First Submitted Date June 8, 2010
First Posted Date June 10, 2010
Last Update Posted Date April 26, 2011
Study Start Date June 2010
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT01141673 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Development of a Diagnostic Kit for FLT3-ITD in Acute Myeloid Leukemia
Official Title Development of a Diagnostic Kit for FLT3-ITD in Acute Myeloid Leukemia
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
DNA
Sampling Method Non-Probability Sample
Study Population acute myeloid leukemia patient in wanfang hospital
Condition Acute Myeloid Leukemia
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: June¬†9,¬†2010)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2011
Primary Completion Date Not Provided
Eligibility Criteria

Inclusion Criteria:

  • Patients with confirmed diagnosis of acute myeloid leukemia

Exclusion Criteria:

  • non
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT01141673
Other Study ID Numbers FLT3-ITD KIT
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Hsingjin Eugene Liu, MD PhD, Taipei Medical University WanFang Hospital
Study Sponsor Taipei Medical University WanFang Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Hsin-Gjin Eugene Liu Taipei Medical University WanFang Hospital
PRS Account Taipei Medical University WanFang Hospital
Verification Date April 2011