Collection of Blood and Urine From Patients Undergoing Radiation Therapy

Sponsor

National Cancer Institute (NCI) (NIH)

Overall Status

Enrolling by invitation

CT.gov ID

NCT00027326

Collaborator

(none)

720

Enrollment

Location

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma Cancer Tumor

Detailed 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

Study Type:

Observational

Anticipated Enrollment :

720 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Dec 2, 2001

Arms and Interventions

Arm	Intervention/Treatment
1/Patients Candidate for or currently receiving radiotherapy

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

INCLUSION CRITERIA:

Patients must be co-enrolled in a NIH CC protocol in which radiation will be administered.
Patients must 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.