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The Expression of PTEN Protein and mRNA in Malignant Cells of Chronic Myelomonocytic Leukemia

This study is currently recruiting participants.
Verified January 2013 by University of Arkansas
Sponsor:
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT01010256
First received: November 6, 2009
Last updated: January 30, 2013
Last verified: January 2013
History of Changes

November 6, 2009
January 30, 2013
November 2009
January 2014   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01010256 on ClinicalTrials.gov Archive Site
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The Expression of PTEN Protein and mRNA in Malignant Cells of Chronic Myelomonocytic Leukemia
The Expression of PTEN Protein and mRNA in Malignant Cells of Chronic Myelomonocytic Leukemia

The purpose of this study is to evaluate the level of a specific protein (PTEN) in the cancer cells of chronic myelomonocytic leukemia (CMML) patients. This protein might be involved in the transformation from normal blood cells to leukemia cells. The PTEN protein has not been investigated in CMML specifically but it has been discovered in closely related cancers. If this study demonstrates an abnormality in this protein, future testing will be designed to evaluate the genetic abnormality that resulted in lack of the normal presence of this protein. The goal is that the results of this study will help to develop new drugs and strategies to treat the future patients with CMML by understanding the abnormality of the disease at the cellular and molecular levels. The results of this study can also be utilized by future studies to develop individualized treatment to patients who have abnormal levels of this protein.
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Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

During routine clinic visits, staff will present the option of participating in this clinical trial to eligible patients with a diagnosis of CMML. Also, healthy control patients will be asked to participate. The healthy control patients can be the subject's family members, friends, or volunteers.
Chronic Myelomonocytic Leukemia
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  • Subjects diagnosed with CMML
    Subjects ages 18 and older with a CMML diagnosis based on the WHO 2009 criteria, and who have signed an informed consent are eligible to participate in the study population of this clinical trial. A total of 12 patients will be consented.
  • Control Group
    The control group will consist of subjects ages 18 years or older who are healthy (i.e. no hematologic disorders) and have signed an informed consent. A total of 10 healthy control subjects will be consented.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
22
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January 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject must be at least 18 years or older.
  • Subject must sign informed consent.
  • For study population only, the subject must have a CMML diagnosis based on the WHO 2009 criteria.
  • For control population only, the subject must be deemed healthy with no hematologic disorders.
Both
18 Years and older
Yes
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United States
 
NCT01010256
111245
No
University of Arkansas
University of Arkansas
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Principal Investigator: Peter Emanuel, MD University of Arkansas
University of Arkansas
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP