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Evaluation of Formin Gene Status and Expression in Myeloproliferative and Myelodysplastic Disorders

Sponsor
Spectrum Health Hospitals (Other)
Overall Status
Completed
CT.gov ID
NCT00687414
Collaborator
Van Andel Research Institute (Other), Community Foundation for Southeast Michigan (JP McCarthy Fund) (Other)
60
Enrollment
2
Locations
21
Duration (Months)
30
Patients Per Site
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Aim of the study is to analyze the expression of genes and sequences encoding the human mammalian diaphanous (mDia) related formin proteins to test the hypothesis that defects in the mDia expression or function might drive the pathophysiology of myelodysplastic syndrome, acute myeloid leukemia and other myeloproliferative diseases.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Leukocytes and myeloid lineage cells from these specimens will be assayed for expression of DRF genes using standard molecular biological approaches to measure mRNA levels. Extracted DNA will be analyzed for mutations that affect expressions or function using direct sequencing techniques.

    Alternatively, expression of DRF gene products (mDia proteins) will be assessed using specific antibodies and flow cytometry. Molecular findings resulting from these assays will be correlated with clinical information recorded in specimen logbook.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of Formin Gene Status and Expression in Myeloproliferative and Myelodysplastic Disorders
    Study Start Date :
    Apr 1, 2008
    Actual Primary Completion Date :
    Dec 1, 2009
    Actual Study Completion Date :
    Jan 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    adults

    male and female with MDS and MPD and AML
    Healthy

    Healthy control group

    Outcome Measures

    Primary Outcome Measures

    1. to determine if defective DRF1 expression or mDia1 function may contribute to myeloid malignancies and point to mDia1 as an attractive therapeutic target in MDS and MPS [within a year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • 18 and over

    • Male

    • Female

    • Diagnosed with MDS, MPD and AML

    Exclusion Criteria:

    • Under the age of 18

    • Received bone marrow transplant

    Control Group Criteria:

    inclusion:

    • healthy men and women

    • ≥ 55 years of age

    exclusion:

    • history of hematological condition

    • history of cancer

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 St Mary's Health Care Grand Rapids Michigan United States 49503
    2 Van Andel Research Institute Grand Rapids Michigan United States 49503

    Sponsors and Collaborators

    • Spectrum Health Hospitals
    • Van Andel Research Institute
    • Community Foundation for Southeast Michigan (JP McCarthy Fund)

    Investigators

    • Principal Investigator: Arthur S Alberts, PhD, Van Andel Research Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00687414
    Other Study ID Numbers:
    • 2008-054 Protocol # 080311 AA
    First Posted:
    May 30, 2008
    Last Update Posted:
    Jan 11, 2010
    Last Verified:
    Jan 1, 2010
    Keywords provided by , ,
    gene expression
    gene sequencing
    gene encoding
    MPD
    MDS
    AML
    mDia
    Additional relevant MeSH terms:
    Myeloproliferative Disorders

    Study Results

    No Results Posted as of Jan 11, 2010