Viewing Study NCT00027326



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Last Modification Date: 2024-10-26 @ 9:06 AM
Study NCT ID: NCT00027326
Status: ENROLLING_BY_INVITATION
Last Update Posted: 2024-07-01
First Post: 2006-07-13

Brief Title: Collection of Blood and Urine From Patients Undergoing Radiation Therapy
Sponsor: National Cancer Institute NCI
Organization: National Institutes of Health Clinical Center CC

Study Overview

Official Title: Collection of Peripheral Blood andor Urine From Patients Undergoing Radiation Therapy
Status: ENROLLING_BY_INVITATION
Status Verified Date: 2024-09-26
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Background

-Research in NCIs 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
Detailed Description: 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 andor 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
02-C-0064 None None None