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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01010256
Recruitment Status : Recruiting
First Posted : November 9, 2009
Last Update Posted : February 21, 2019
Information provided by (Responsible Party):
University of Arkansas

Brief Summary:
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.

Condition or disease
Chronic Myelomonocytic Leukemia

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Study Type : Observational
Estimated Enrollment : 22 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Expression of PTEN Protein and mRNA in Malignant Cells of Chronic Myelomonocytic Leukemia
Actual Study Start Date : November 1, 2009
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.

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.

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 identifier (NCT number): NCT01010256

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United States, Arkansas
University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Beth Scanlan   
Principal Investigator: Peter Emanuel, MD         
Sponsors and Collaborators
University of Arkansas
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Principal Investigator: Peter Emanuel, MD University of Arkansas

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Responsible Party: University of Arkansas Identifier: NCT01010256     History of Changes
Other Study ID Numbers: 111245
First Posted: November 9, 2009    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019

Keywords provided by University of Arkansas:
To evaluate the phosphate and tension homolog deleted on chromosome ten (PTEN) protein level in leukemia cells from patients with CMML.
To identify the PTEN genetic defect in patients with deficient PTEN protein levels.
To evaluate the role of PTEN deregulation in CMML pathogenesis.

Additional relevant MeSH terms:
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Leukemia, Myelomonocytic, Acute
Leukemia, Myelomonocytic, Chronic
Leukemia, Myelomonocytic, Juvenile
Neoplasms by Histologic Type
Leukemia, Myeloid
Myelodysplastic-Myeloproliferative Diseases
Bone Marrow Diseases
Hematologic Diseases