Collection of Blood and Urine From Patients Undergoing Radiation Therapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00027326
First received: July 13, 2006
Last updated: July 26, 2014
Last verified: July 2014

July 13, 2006
July 26, 2014
December 2001
Not Provided
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 ]
Not Provided
Complete list of historical versions of study NCT00027326 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Collection of Blood and Urine From Patients Undergoing Radiation Therapy
Collection of Peripheral Blood and/or 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.

BACKGROUND:

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.

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.

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Not Provided
Not Provided
  • Carcinoma
  • Cancer
  • Tumor
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
Not Provided
Not Provided
  • INCLUSION CRITERIA:

    1. Patients must a candidate for, or currently receiving radiotherapy.
    2. Age greater than or equal to 18 years.

EXCLUSION CRITERIA:

  1. Inability to provide informed consent.
  2. Patients who have unobtainable data regarding previous radiation therapy.
Both
18 Years to 90 Years
No
Contact: Sharon L Smith, R.N. (301) 451-8905 smiths@mail.nih.gov
Contact: Kevin A Camphausen, M.D. (301) 496-5457 camphauk@mail.nih.gov
United States
 
NCT00027326
020064, 02-C-0064
Not Provided
Not Provided
National Cancer Institute (NCI)
Not Provided
Principal Investigator: Kevin A Camphausen, M.D. National Cancer Institute (NCI)
National Institutes of Health Clinical Center (CC)
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP