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

July 26, 2023 updated by: Spectrum Health Hospitals
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • St Mary's Health Care
      • Grand Rapids, Michigan, United States, 49503
        • Van Andel Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Community sample

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
adults
male and female with MDS and MPD and AML
Healthy
Healthy control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
within a year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spectrum Health Hospitals

Collaborators

Van Andel Research Institute
Community Foundation for Southeast Michigan (JP McCarthy Fund)

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

May 27, 2008

First Submitted That Met QC Criteria

May 29, 2008

First Posted (Estimated)

May 30, 2008

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 26, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-054

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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