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
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.
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Kontakty a umístění
Studijní místa
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Kentucky
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Louisville, Kentucky, Spojené státy, 40202
- James Graham Brown Cancer Center-University of Louisville
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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13C-glucose
experimental (13C-glucose)
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No glucose
control (no glucose)
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Metabolic characteristics of leukemic cells from blood and urine samples using nuclear magnetic resonance spectroscopy (NMR)
Časové okno: Baseline up to 6 months post treatment
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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.
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Baseline up to 6 months post treatment
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- BCC-BMT-13 Leuk Metabolomics
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