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临床试验/NCT00027326
NCT00027326Enrolling By Invitation不适用

Collection of Peripheral Blood and/or Urine From Patients Undergoing Radiation Therapy

National Cancer Institute (NCI)1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2001年12月2日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
1,000
试验地点
1
主要终点
To acquire peripheral blood and/or urine samples from patients receiving radiation therapy in the Radiation Oncology Branch, NCI.

研究概览

简要总结

Background:

-Research in NCI's Radiation Oncology Branch depends on the availability of blood and urine samples from patients receiving radiation therapy.

Objectives:

-To explore the effects of radiation therapy on gene expression in white blood cells, to measure radiation damage in red blood cells and to examine changes in hormone levels in the blood and urine after radiation therapy.

Eligibility:

-Patients 18 years of age and older who are receiving radiation therapy.

Design:

  • Blood and urine samples are collected when participants enter the study.
  • Additional samples may be collected at different times during and after treatment. Ideally, samples are obtained before, at the completion of, and 1 month following radiation therapy. Blood samples usually will be collected during routine patient monitoring procedures and will not require an additional needle stick.
  • A total of 300 patients will be studied at the NCI in Bethesda, MD, Johns Hopkins University in Baltimore and the University of Pennsylvania in Philadelphia.

详细描述

BACKGROUND:

Evolving research initiatives in the Radiation Oncology Branch (ROB) NCI, depend upon the availability of blood and urine samples from patients receiving radiotherapy.

Examples of planned studies include an exploration of the effects of radiotherapy on peripheral leukocyte phenotype, peripheral blood protein and metabolism changes as well as measurements of matrix metalloproteinases (MMP) in urine.

OBJECTIVES:

This protocol provides a means of acquiring blood and urine samples in patients receiving radiation therapy for a variety of conditions.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 120 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •INCLUSION CRITERIA:
  • •Patients must be co-enrolled in a NIH CC protocol in which radiation will be administered.
  • •Patients must be a candidate for, or currently receiving radiotherapy.
  • •Age greater than or equal to 18 years.
  • •Ability of subject or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.

排除标准

  • •1. Patients who have unobtainable data regarding previous radiation therapy.

研究组 & 干预措施

1/Patients

Candidate for or currently receiving radiotherapy

结局指标

主要结局

To acquire peripheral blood and/or urine samples from patients receiving radiation therapy in the Radiation Oncology Branch, NCI.

时间窗: At the time of the enrollment, a blood and/or a urine sample will be collected. Blood and/or urine will also be collected at the completion of radiotherapy and at 1 month follow- up.

collection of blood and urine

次要结局

未报告次要终点

研究者

申办方类型
Nih
责任方
Sponsor

研究点 (1)

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