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

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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02193100
Enrollment
0
Registered
2014-07-17
Start date
2014-08-31
Completion date
2019-06-30
Last updated
2017-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia

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.

Interventions

None listed

Sponsors

James Graham Brown Cancer Center
CollaboratorOTHER
University of Louisville
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Metabolic characteristics of leukemic cells from blood and urine samples using nuclear magnetic resonance spectroscopy (NMR)Baseline up to 6 months post treatmentBlood and urine samples will be taken before and after chemotherapy treatment for up to 6 months post treatment and analyzed for metabolic substances using nuclear magnetic resonance (NMR) spectroscopy with intergraded hyphenated mass spectrometry.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026