Collection of Blood and Urine From Patients Undergoing Radiation Therapy
|First Received Date ICMJE||July 13, 2006|
|Last Updated Date||July 26, 2014|
|Start Date ICMJE||December 2001|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||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 ]|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00027326 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Collection of Blood and Urine From Patients Undergoing Radiation Therapy|
|Official Title ICMJE||Collection of Peripheral Blood and/or 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.
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.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Time Perspective: Prospective|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||300|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years to 90 Years|
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00027326|
|Other Study ID Numbers ICMJE||020064, 02-C-0064|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Cancer Institute (NCI)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||July 2014|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP