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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Taipei Medical University WanFang Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier:
NCT01141673
First received: June 8, 2010
Last updated: April 22, 2011
Last verified: April 2011
  Purpose

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
Acute Myeloid Leukemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development of a Diagnostic Kit for FLT3-ITD in Acute Myeloid Leukemia

Resource links provided by NLM:


Further study details as provided by Taipei Medical University WanFang Hospital:

Biospecimen Retention:   Samples With DNA

DNA


Estimated Enrollment: 100
Study Start Date: June 2010
Estimated Study Completion Date: June 2011
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

acute myeloid leukemia patient in wanfang hospital

Criteria

Inclusion Criteria:

  • Patients with confirmed diagnosis of acute myeloid leukemia

Exclusion Criteria:

  • non
  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: NCT01141673

Contacts
Contact: Hsin-Gjin Eugene Liu 886-2-29307930 ext 2548 liuxx086@gmail.com

Locations
Taiwan
Taipei Medical University - WanFang Hospital Recruiting
Taipei, Taiwan
Contact: Hsin-Gjin Eugene Liu    886-2-29307930 ext 2548    liuxx086@gmail.com   
Sponsors and Collaborators
Taipei Medical University WanFang Hospital
Investigators
Principal Investigator: Hsin-Gjin Eugene Liu Taipei Medical University WanFang Hospital
  More Information

No publications provided

Responsible Party: Hsingjin Eugene Liu, MD PhD, Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier: NCT01141673     History of Changes
Other Study ID Numbers: FLT3-ITD KIT
Study First Received: June 8, 2010
Last Updated: April 22, 2011
Health Authority: Taiwan: Department of Health

Keywords provided by Taipei Medical University WanFang Hospital:
FLT3-ITD
acute myeloid leukemia
FLT3
D835

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

ClinicalTrials.gov processed this record on September 16, 2014