USDOE Human Subjects Research Database, Fiscal Year 2007

University of California, Davis

Public Information Contact:

Dr. David M. Rocke
Division of Biostatistics, Med Sci 1C
One Shields Ave
University of California, Davis
Davis, CA 95616

Phone: (530) 752-6999
Fax: (530) 754-67
E-mail: dmrocke@ucdavis.edu

Institutional Review Board (IRB):

Projects are approved by an IRB located at: University of California, Davis
The approving IRB operates under an OHRP assurance.
OHRP assurance number: 00004557

Human Subject Projects:

Number of Human Subjects projects reported: 1

UCD-07-DE-FG02-07ER64341 "Genome-Wide Evaluation of Normal Human Tissue in Response to Controlled, In Vivo Low-Dose Low LET Ionizing Radiation Exposure: Pathways and Mechanisms"

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Project Identifier: UCD-07-DE-FG02-07ER64341

Project Title:
"Genome-Wide Evaluation of Normal Human Tissue in Response to Controlled, In Vivo Low-Dose Low LET Ionizing Radiation Exposure: Pathways and Mechanisms"

Principal Investigator: Dr. David M. Rocke, University of California, Davis

Project started in: 2007

Status of the Research this Fiscal Year:
  Study is not currently enrolling subjects or enrollment of participants is currently suspended, but may resume in the future.

Project Funding Information:

This project received funding during fiscal year 2007.

Funding for Human Subjects Research:

DOE: Office of Biological and Environmental Research (OBER)
$310,000.00 (Est.) for: Fiscal Year 2007
Analysis of human biopsy samples only, no new subjects currently being enrolled.
Percent of funding associated with the use of human subjects: 1-20

Information on Use of Human Subjects:

This project does not involve the use of multiple protocols/subprojects.

Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: University of California, Davis
Most recent approval: 04/09/07

Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects: Fiscal Year 2007

Type(s) of Human Subjects Involvement:

Abstract:

(a. Objectives, b. Methodology, c. Ionizing Radiation, Radioactive Substances, or Chemical Substances to which human subjects are exposed, d. Involvement of Human Subjects [d.1. procedures used, d.2. risks if any])

The goal of this project is to analyze data from skin punch biopsies from patient-volunteers undergoing therapeutic radiation to assess gene and protein expression changes in cells exposed to extremely low dose (<1-10 cGy) ionizing radiation (IR). Skin that had been calculated to receive 0 or 100 cGy IR in a single dose was also biopsied to provide the negative and positive control samples, respectively. The overall goals of the project are to establish in vivo data to evaluate the "linear no-threshold" model of radiation responses. This study will use only existing biopsy samples taken under this protocol by Dr. Goldberg prior to 12/31/2006.

Go to list of projects at University of California, Davis