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

Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02193100
• Other study ID #: BCC-BMT-13 Leuk Metabolomics
• Status: Withdrawn
• Phase: N/A
• First received: June 12, 2014
• Last updated: December 27, 2017
• Start date: August 2014
• Est. completion date: June 2019

Study information

• Verified date: January 2016
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2019
• Est. primary completion date: June 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leukemia

Locations

Country	Name	City	State
United States	James Graham Brown Cancer Center-University of Louisville	Louisville	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
University of Louisville	James Graham Brown Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolic characteristics of leukemic cells from blood and urine samples using nuclear magnetic resonance spectroscopy (NMR)	Blood 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.	Baseline up to 6 months post treatment