Clinical trial NCT02193100: Pre and Post Treatment Metabolomic Analysis of Leukemia: A Translational Clinical Trial of the Brown Cancer Center
Official title: PRE AND POST TREATMENT METABOLOMIC ANALYSIS OF LEUKEMIA: A Translational Clinical Trial of the Brown Cancer Center
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Leukemia
Lead sponsor: University of Louisville
Sponsor class: OTHER
Collaborators: name: James Graham Brown Cancer Center
First posted: 2014-07-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Leukemia Subjects-clinically diagnosed or histologically diagnosed leukemia Healthy Subjects-no record of diagnosed cancer or hematologic disorders

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 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.

Eligibility 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

Primary outcomes:
measure: Metabolic characteristics of leukemic cells from blood and urine samples using nuclear magnetic resonance spectroscopy (NMR)
timeFrame: Baseline up to 6 months post treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: James Graham Brown Cancer Center-University of Louisville
state: Kentucky
Study officials:
References: