Clinical trial NCT00027326: Collection of Blood and Urine From Patients Undergoing Radiation Therapy
Official title: Collection of Peripheral Blood and/or Urine From Patients Undergoing Radiation Therapy
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Carcinoma
Cancer
Tumor
Keywords: Blood
Samples
Radiation
Urine
Cancer
Natural History
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2001-12-03
Enrollment: 720
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients currently a candidate or currently receiving radiotherapy.

Brief summary: 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.

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 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.

Eligibility criteria: * INCLUSION CRITERIA:

  1. Patients must be co-enrolled in a NIH CC protocol in which radiation will be administered.
  2. Patients must a candidate for, or currently receiving radiotherapy.
  3. Age greater than or equal to 18 years.
  4. Ability of subject or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.

EXCLUSION CRITERIA:

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

Primary outcomes:
measure: To acquire peripheral blood and/or urine samples from patients receiving radiation therapy in the Radiation Oncology Branch, NCI.
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: National Cancer Institute (NCI)
name: Kevin A Camphausen, M.D.
role: PRINCIPAL_INVESTIGATOR
References: