Protocol Number: 02-C-0064

Title:

Collection of Peripheral Blood and/ or Urine From Patients Undergoing Radiation Therapy

Number:

02-C-0064

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.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA:

1.) Patients must a candidate for, or currently receiving radiotherapy.

2.) Age greater than or equal to 18 years.

EXCLUSION CRITERIA:

1.) Inability to provide informed consent.

2.) Patients who have unobtainable data regarding previous radiation therapy.

Special Instructions:

Currently Not Provided

Keywords:

Blood

Urine

Radiation

Non-Therapeutic

Cancer

Recruitment Keyword(s):

Radiation

Radiation Therapy

Condition(s):

Neoplasms

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Cancer Institute

Contact(s):

Sharon L. Smith, R.N.
National Institutes of Health
Building 10
Room B2-3500
10 Center Drive
Bethesda, Maryland 20892
Phone: (301) 451-8905
Fax: (301) 480-0647
Electronic Address: smith@mail.nih.gov

Citation(s):

Amundson SA, Bittner M, Chen Y, Trent J, Meltzer P, Fornace AJ Jr. Fluorescent cDNA microarray hybridization reveals complexity and heterogeneity of cellular genotoxic stress responses. Oncogene. 1999 Jun 17;18(24):3666-72. PMID: 10380890

Amundson SA, Do KT, Fornace AJ Jr. Induction of stress genes by low doses of gamma rays. Radiat Res. 1999 Sep;152(3):225-31. PMID: 10453082

Amundson SA, Do KT, Shahab S, Bittner M, Meltzer P, Trent J, Fornace AJ Jr. Identification of potential mRNA biomarkers in peripheral blood lymphocytes for human exposure to ionizing radiation. Radiat Res. 2000 Sep;154(3):342-6. PMID: 11012342

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
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