Enrolling by Invitation

NCT Number: NCT00027326

Collection of Blood and 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.

Enrolling by Invitation

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Key information

Conditions

Carcinoma Cancer Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Tumor

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Exclusion criteria

Patients who have unobtainable data regarding previous radiation therapy.

Treatment and study plan

Primary outcomes

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

Time frame: 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

Sponsors and collaborators

Lead sponsor

National Cancer Institute (NCI)

Nih

Registry information

Official study title

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

Important dates

Study start: 2001
First posted: Dec 3, 2001
Registry last updated: Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed