The Expression of PTEN Protein and mRNA in Malignant Cells of Chronic Myelomonocytic Leukemia
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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 |
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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 |
| Estimated Enrollment: | 22 |
| Study Start Date: | November 2009 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
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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.
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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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Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | 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.
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| 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 | |
| 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: | January 30, 2013 |
| 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:
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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 May 22, 2013