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

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ClinicalTrials.gov Identifier: NCT01010256
Recruitment Status : Recruiting
First Posted : November 9, 2009
Last Update Posted : February 21, 2019
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

Tracking Information
First Submitted Date November 6, 2009
First Posted Date November 9, 2009
Last Update Posted Date February 21, 2019
Actual Study Start Date November 1, 2009
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT01010256 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Expression of PTEN Protein and mRNA in Malignant Cells of Chronic Myelomonocytic Leukemia
Official Title The Expression of PTEN Protein and mRNA in Malignant Cells of Chronic Myelomonocytic Leukemia
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Chronic Myelomonocytic Leukemia
Intervention Not Provided
Study 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November¬†6,¬†2009)
22
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2020
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01010256
Other Study ID Numbers 111245
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Arkansas
Study Sponsor University of Arkansas
Collaborators Not Provided
Investigators
Principal Investigator: Peter Emanuel, MD University of Arkansas
PRS Account University of Arkansas
Verification Date February 2019