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

2017年12月27日 更新者:University of Louisville

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.

研究概览

地位

撤销

条件

详细说明

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.

研究类型

观察性的

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Kentucky
      • Louisville、Kentucky、美国、40202
        • James Graham Brown Cancer Center-University of Louisville

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Leukemia Subjects-clinically diagnosed or histologically diagnosed leukemia Healthy Subjects-no record of diagnosed cancer or hematologic disorders

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
13C-glucose
experimental (13C-glucose)
No glucose
control (no glucose)

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Metabolic characteristics of leukemic cells from blood and urine samples using nuclear magnetic resonance spectroscopy (NMR)
大体时间:Baseline up to 6 months post treatment
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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2014年8月1日

初级完成 (预期的)

2018年6月1日

研究完成 (预期的)

2019年6月1日

研究注册日期

首次提交

2014年6月12日

首先提交符合 QC 标准的

2014年7月15日

首次发布 (估计)

2014年7月17日

研究记录更新

最后更新发布 (实际的)

2017年12月29日

上次提交的符合 QC 标准的更新

2017年12月27日

最后验证

2016年1月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • BCC-BMT-13 Leuk Metabolomics

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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