Collection of Blood and Urine From Patients Undergoing Radiation Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00027326
Recruitment Status : Recruiting
First Posted : December 3, 2001
Last Update Posted : October 8, 2018
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief Summary:


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


-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.


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


  • 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
Carcinoma Cancer Tumor

Detailed Description:


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.


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


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


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 Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Collection of Peripheral Blood and/or Urine From Patients Undergoing Radiation Therapy
Study Start Date : December 6, 2001

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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. ]
    Radiation therapy

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients currently a candidate or currently receiving radiotherapy.

    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.


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00027326

Contact: Theresa Cooley-Zgela, R.N. (240) 760-6207
Contact: Kevin A Camphausen, M.D. (240) 760-6205

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office    (888) NCI-1937      
Sponsors and Collaborators
National Cancer Institute (NCI)
Principal Investigator: Kevin A Camphausen, M.D. National Cancer Institute (NCI)