Cancer Clinical Trial - Collection of Blood & Urine From Patients

Status Enrolling by invitation

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00027326
Study type	Observational
Source	National Institutes of Health Clinical Center (CC)
Contact
Status	Enrolling by invitation
Phase
Start date	December 2, 2001

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Collection of Blood and Urine From Patients Undergoing Radiation Therapy

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms