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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University of Arkansas
Sponsor:
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT01010256
First received: November 6, 2009
Last updated: August 14, 2014
Last verified: August 2014
  Purpose

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
Chronic Myelomonocytic Leukemia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Expression of PTEN Protein and mRNA in Malignant Cells of Chronic Myelomonocytic Leukemia

Resource links provided by NLM:


Further study details as provided by University of Arkansas:

Estimated Enrollment: 22
Study Start Date: November 2009
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01010256

Locations
United States, Arkansas
University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Suzy Hall       Hallsusanf@uams.edu   
Principal Investigator: Peter Emanuel, MD         
Sponsors and Collaborators
University of Arkansas
Investigators
Principal Investigator: Peter Emanuel, MD University of Arkansas
  More Information

No publications provided

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT01010256     History of Changes
Other Study ID Numbers: 111245
Study First Received: November 6, 2009
Last Updated: August 14, 2014
Health Authority: United States: Institutional Review Board

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:
Leukemia
Leukemia, Myelomonocytic, Chronic
Leukemia, Myelomonocytic, Acute
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid
Myelodysplastic-Myeloproliferative Diseases
Bone Marrow Diseases
Hematologic Diseases

ClinicalTrials.gov processed this record on August 28, 2014