Collection of Blood and Urine From Patients Undergoing Radiation Therapy

NCT00027326 | Enrolling By Invitation

• 2 other identifiers: 02006402-C-0064
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Carcinoma; Tumor

Keywords

Blood; Samples; Radiation; Urine; Cancer; Natural History

Outcome Measures

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

  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.

Study Arms (1)

1/Patients

Candidate for or currently receiving radiotherapy

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients currently a candidate or currently receiving radiotherapy.

You may qualify if:

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

You may not qualify if:

• \. Patients who have unobtainable data regarding previous radiation therapy.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Carcinoma; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Kevin A Camphausen, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2006
• First Posted: December 3, 2001
• Study Start: December 2, 2001
• Last Updated: May 7, 2026

Record last verified: 2026-04-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Clinical data available during the study and indefinitely.
• Access Criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.

Locations

US (1)