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Enrolling by invitationNCT00027326Updated Sep 29, 2026

Collection of Blood and Urine From Patients Undergoing Radiation Therapy

An observational study in Carcinoma, Cancer and Tumor, sponsored by National Cancer Institute (NCI). Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by National Cancer Institute (NCI) · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years to 120 Years
Sex
All
01

Study 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.
Read the 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.

02

Conditions studied

  • Carcinoma
  • Cancer
  • Tumor

Keywords

  • Blood
  • Samples
  • Radiation
  • Urine
  • Cancer
  • Natural History
03

Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients currently a candidate or currently receiving radiotherapy.

Inclusion criteria

  1. Patients must be co-enrolled in a NIH CC protocol in which radiation will be administered.

    1. Patients must be a candidate for, or currently receiving radiotherapy.
    2. Age greater than or equal to 18 years.
    3. Ability of subject or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.

Exclusion criteria

EXCLUSION CRITERIA:

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

04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)

Groups and cohorts

  • 1/Patients

    Candidate for or currently receiving radiotherapy

05

What researchers measure

Primary outcomes

  1. To acquire peripheral blood and/or urine samples from patients receiving radiation therapy in the Radiation Oncology Branch, NCI.

    collection of blood and urine

    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.

06

Study locations

1 site
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
07

References and documents

Individual participant data

Plan to share: Yes — All IPD recorded in the medical record will be shared with intramural investigators upon request.

Supporting information: Study protocol, Sap, Icf

08

Registry details

Key details

Study ID
NCT00027326
Lead sponsor
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Dec 3, 2001
Start date
Dec 2, 2001
Last update
Sep 29, 2026

Study contacts

Kevin A Camphausen, M.D.
principal investigator · National Cancer Institute (NCI)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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