Status:
WITHDRAWN
Pre and Post Treatment Metabolomic Analysis of Leukemia: A Translational Clinical Trial of the Brown Cancer Center
Lead Sponsor:
University of Louisville
Collaborating Sponsors:
James Graham Brown Cancer Center
Conditions:
Leukemia
Eligibility:
All Genders
18+ years
Brief Summary
To characterize the metabolism of glucose by the leukemic cells in patients with leukemia before and after initial chemotherapy. To compare the metabolism of glucose by leukocytes in healthy voluntee...
Detailed Description
To characterize glycolytic metabolism in patients as demonstrated in leukemic cells and serum metabolite analysis after C13-glucose administration at strategic time points of treatment. To detect and...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Leukemia Subjects:
- Each of the criteria in the following section must be met in order for a patient to be eligible for enrollment.
- Only patients with clinically diagnosed or histologically diagnosed leukemia will be eligible to participate in this non-therapeutic study.
- All patients must have measurable quantities of leukemic blasts on peripheral blood detected with a CBC.
- No history of diabetes for the experimental group or the control group.
- Patients with known hepatitis C or HIV (AIDS) are excluded.
- Patients must be informed of the investigational nature of this study and sign and give written informed consent in accordance with institutional and federal guidelines.
- Inclusion Criteria forHealthy Subjects:
- Subjects must have no known prior history of cancer or malignant blood disorders. -Where possible, follow up will be carried out to verify that no cancer has developed since the blood collection. This will be done by a phone call performed one month from sample to ask if new medical conditions have arisen.
- Subjects must have WBC, RBC, and platelet counts within normal range on CBC.
- Subjects with known hepatitis C or HIV (AIDS) are excluded.
- No history of Diabetes
- At least 30 years of age
- Preferably be fasting for 12 hours (minimum 8 hours) prior to enrollment
- Patients must be informed of the investigational nature of this study and sign and give written informed consent in accordance with institutional and federal guidelines.
- Exclusion Criteria:
- None listed in protocol
Exclusion
Key Trial Info
Start Date :
August 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02193100
Start Date
August 1 2014
End Date
June 1 2019
Last Update
December 29 2017
Active Locations (1)
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1
James Graham Brown Cancer Center-University of Louisville
Louisville, Kentucky, United States, 40202