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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-31

Study Completion Date

2019-06-30

Brief Summary

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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

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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.

Conditions

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Leukemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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13C-glucose

experimental (13C-glucose)

No interventions assigned to this group

No glucose

control (no glucose)

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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.

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Locations

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James Graham Brown Cancer Center-University of Louisville

Louisville, Kentucky, United States

Site Status

Countries

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United States

Other Identifiers

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BCC-BMT-13 Leuk Metabolomics

Identifier Type: -

Identifier Source: org_study_id