Collection of Blood and Urine From Patients Undergoing Radiation Therapy



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 90
Updated:4/4/2019
Start Date:February 6, 2002
Contact:Theresa Cooley-Zgela, R.N.
Email:theresa.cooleyzgela@nih.gov
Phone:(240) 760-6207

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

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.

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.

ELIGIBILITY:

Patients seen in the radiation oncology clinic will be asked to donate blood and/or urine
before, during and after their treatment.

DESIGN:

This is a pilot, exploratory study to evaluate the effects of ionizing radiation in blood
and/ or urine.

On most occasions, the blood samples will be obtained as a component of routine patient
monitoring and will not necessitate an additional venipuncture.

Blood and urine samples will be processed and stored in the Radiation Oncology Branch and
Basic Research Laboratory, CCR, NCI, for use in the research efforts of the branch.

- INCLUSION CRITERIA:

1. Patients must a candidate for, or currently receiving radiotherapy.

2. Age greater than or equal to 18 years.

3. Ability of subject or Legally Authorized Representative (LAR) to understand and
the willingness to sign a written informed consent document.

EXCLUSION CRITERIA:

1.) Patients who have unobtainable data regarding previous radiation therapy.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Phone: (888) NCI-1937
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mi
from
Bethesda, MD
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