- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01010256
The Expression of PTEN Protein and mRNA in Malignant Cells of Chronic Myelomonocytic Leukemia
February 5, 2020 updated by: University of Arkansas
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.
Study Overview
Status
Terminated
Conditions
Study Type
Observational
Enrollment (Actual)
4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arkansas
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Little Rock, Arkansas, United States, 72205
- University of Arkansas for Medical Sciences
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Peter Emanuel, MD, University of Arkansas
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2009
Primary Completion (Actual)
October 3, 2019
Study Completion (Actual)
October 3, 2019
Study Registration Dates
First Submitted
November 6, 2009
First Submitted That Met QC Criteria
November 6, 2009
First Posted (Estimate)
November 9, 2009
Study Record Updates
Last Update Posted (Actual)
February 7, 2020
Last Update Submitted That Met QC Criteria
February 5, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 111245
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Myelomonocytic Leukemia
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Humanigen, Inc.CompletedChronic Myelomonocytic Leukemia (CMML)United States
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University of UtahCelgeneCompletedChronic Myelomonocytic LeukemiaUnited States
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National Heart, Lung, and Blood Institute (NHLBI)CompletedChronic Myelomonocytic Leukemia | Chronic Myelogenous LeukemiaUnited States
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