Pre and Post Treatment Metabolomic Analysis of Leukemia: A Translational Clinical Trial of the Brown Cancer Center



Status:Withdrawn
Conditions:Blood Cancer, Leukemia
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/31/2017
Start Date:August 2014
End Date:June 2019

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PRE AND POST TREATMENT METABOLOMIC ANALYSIS OF LEUKEMIA: A Translational Clinical Trial of the Brown Cancer Center

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 volunteers and leukemic cells
in leukemic patients.

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 measure 13C-labeled metabolic markers which may be present in the serum and
urine of leukemic patients.

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 measure 13C-labeled metabolic markers which may be present in the serum and
urine of leukemic patients.

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
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