- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02193100
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.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Contatti e Sedi
Luoghi di studio
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Kentucky
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Louisville, Kentucky, Stati Uniti, 40202
- James Graham Brown Cancer Center-University of Louisville
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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13C-glucose
experimental (13C-glucose)
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No glucose
control (no glucose)
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Metabolic characteristics of leukemic cells from blood and urine samples using nuclear magnetic resonance spectroscopy (NMR)
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Collaboratori
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- BCC-BMT-13 Leuk Metabolomics
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .