- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01460238
Lipoprotein Lipase Expression in Chronic Lymphocytic Leukemia
March 27, 2019 updated by: Frederick Lansigan, Dartmouth-Hitchcock Medical Center
The investigators hypothesize that Lipoprotein Lipase (LPL) expression on Chronic Lymphocytic Leukemia (CLL) cells will predict a more aggressive clinical course.
The results from this proposal will validate the use of a novel antibody developed at Dartmouth-Hitchcock in CLL and will predict CLL patients that have a more aggressive form of the disease.
The investigators work will also provide direct evidence that LPL is expressed on CLL cells and provides a critical source of fatty acids required by the CLL cells to grow and survive.
Fatty acid metabolism may become a therapeutic target in CLL in the future.
Study Overview
Status
Completed
Conditions
Detailed Description
The investigators plan to use a novel antibody developed at Dartmouth-Hitchcock Medical Center to characterize the expression of LPL in CLL.
Peripheral blood from CLL patients will be analyzed by flow cytometry to detect the expression of LPL and to investigate if LPL expression correlates with a more aggressive type of CLL.
The investigators propose that LPL protein expression on CLL cells is prognostic and that LPL and other proteins involved in fatty acid metabolism are critical for CLL cells to survive.
Study Type
Observational
Enrollment (Actual)
29
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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New Hampshire
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Lebanon, New Hampshire, United States, 03756
- Dartmouth-Hitchcock Medical Center
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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
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients at Dartmouth-Hitchcock Medical Center's Norris Cotton Cancer Center with CLL
Description
Inclusion Criteria:
- Diagnosis of CLL as per National Cancer Institute Working Group Guidelines
- Patients undergoing routine blood draws as part of their ongoing follow up for CLL
- 18 years or older
- Ability to provide consent in English
- Patient must have measurable disease as defined by an absolute lymphocyte count greater than 5,000/mm3 or have archived lymph node or bone marrow with CLL involvement.
Exclusion Criteria:
- Patients who have received cytotoxic drug, oral or intravenous steroid or targeted antibody therapy for their CLL,
- other hematologic malignancy or other disease process within the past 6 months are excluded.
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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No treatment
No intervention.
Each patient will have blood drawn at a standard of care venipuncture.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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LPL Protein Expression
Time Frame: 1 year
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Determine the degree of LPL protein expression in CLL cells using a novel LPL antibody, correlate with IgHV mutation status, and compare this association with other prognostic markers
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1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fatty acid acquisition and synthesis
Time Frame: 1 year
|
Demonstrate that CLL cells also possess the enzymatic machinery for fatty acid acquisition and synthesis as shown by the expression of LPL, CD36, SDC1, and fatty acid synthase
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1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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
October 1, 2011
Primary Completion (Actual)
May 1, 2018
Study Completion (Actual)
May 1, 2018
Study Registration Dates
First Submitted
October 24, 2011
First Submitted That Met QC Criteria
October 25, 2011
First Posted (Estimate)
October 26, 2011
Study Record Updates
Last Update Posted (Actual)
March 28, 2019
Last Update Submitted That Met QC Criteria
March 27, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D11065
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.
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