Pre and Post Treatment Metabolomic Analysis of Leukemia: A Translational Clinical Trial of the Brown Cancer Center
Conditions
Leukemia
Conditions: official terms
Leukemia
Study Type
Observational
Study Phase
Phase 1/Phase 2
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Overall Status
Recruiting
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 volunteers and leukemic cells in leukemic patients.
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 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.
Criteria for eligibility
Healthy Volunteers: Accepts Healthy Volunteers
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Location
James Graham Brown Cancer Center-University of Louisville
Louisville, Kentucky, United States
Status: Recruiting
Contact: Cesar Rodriguez - 502-562-4359
Start Date
August 2014
Completion Date
June 2019
Sponsors
James Graham Brown Cancer Center
Source
James Graham Brown Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page