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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00687414
First Posted: May 30, 2008
Last Update Posted: January 11, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Van Andel Research Institute
Community Foundation for Southeast Michigan (JP McCarthy Fund)
Information provided by:
Spectrum Health Hospitals
  Purpose
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
Myeloproliferative Disorder MDS AML

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Evaluation of Formin Gene Status and Expression in Myeloproliferative and Myelodysplastic Disorders

Resource links provided by NLM:


Further study details as provided by Spectrum Health Hospitals:

Primary Outcome Measures:
  • 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 [ Time Frame: within a year ]

Biospecimen Retention:   Samples With DNA
peripheral blood

Estimated Enrollment: 60
Study Start Date: April 2008
Study Completion Date: January 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
adults
male and female with MDS and MPD and AML
Healthy
Healthy control group

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Community sample
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00687414


Locations
United States, Michigan
St Mary's Health Care
Grand Rapids, Michigan, United States, 49503
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
  More Information

Responsible Party: Arthur S. Alberts, Ph.D., Van Andel Research Institute
ClinicalTrials.gov Identifier: NCT00687414     History of Changes
Other Study ID Numbers: 2008-054 Protocol # 080311 AA
First Submitted: May 27, 2008
First Posted: May 30, 2008
Last Update Posted: January 11, 2010
Last Verified: January 2010

Keywords provided by Spectrum Health Hospitals:
gene expression
gene sequencing
gene encoding
MPD
MDS
AML
mDia

Additional relevant MeSH terms:
Disease
Myeloproliferative Disorders
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases