Collection of Blood and Urine From Patients Undergoing Radiation Therapy
-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.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Collection of Peripheral Blood and/or Urine From Patients Undergoing Radiation Therapy|
- 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. ] [ Designated as safety issue: No ]
|Study Start Date:||December 2001|
Evolving research initiatives in the Radiation Oncology Branch (ROB) and the Radiation Oncology Sciences Program (ROSP), 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 blood lymphocyte gene expression, evaluation of cytogenetic damage in immature red blood cells, and 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00027326
|Contact: Theresa Cooley-Zgela, R.N.||(301) 496-0684|
|Contact: Kevin A Camphausen, M.D.||(301) email@example.com|
|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|
|Principal Investigator:||Kevin A Camphausen, M.D.||National Cancer Institute (NCI)|