USDOE Human Subjects Research Database, fiscal year 1995

Lawrence Livermore National Laboratory

Project Identifier: LLNL-95-119

Project Title:

Chromosome Painting

Principle Investigator: Dr. Joe N. Lucas

Project started in: 1995

Fiscal Year 1995 Funding for Research on Human Subjects:

Project Funding Information:
Project received funding in Fiscal Year 1995.
Project used human subjects in Fiscal Year 1995.

Funding Sources:

DOE: DOE/Energy Research

Amount: $100,000 (Est.)

Information on Use of Human Subjects:

Project does not involve use of multiple protocols/subprojects.

IRB Review:
Type of Review: Full Board
Most Recent Approval: July 19, 1995
IRB Approval Number: 95-119

Number of Human Subjects in the Last Reporting Period for this Project: 15
(Reporting periods vary.)

Type of Human Subjects Involvement:

Collection of Bodily Materials:

Collection of personally identifiable bodily materials (blood or blood products, cells, tissue, organs, waste).

• Use of cells cultured in a laboratory.
• Use of existing bodily materials that were collected for another purpose or project.

(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 develop and validate improved procedures for assessment of radiation-induced genetic damage. These studies may lead to procedures for a more accurate assessment of exposure in accidentally or occupationally exposed individuals (a) to guide medical treatment or to establish improved correlation between exposure and untoward medical consequences, (b) to improve our understanding of the genetic consequences of exposure to low levels of ionizing radiation and (c) to increase the sensitivity with which low levels of radiation exposure can be assessed. An essential requirement for the use of biomarkers in exposure assessment and dosimetry is quantification of the parameters that drive the overall uncertainty. In the simplest case (i.e., under conditions where aD defines the dose-response relationship), only three parameters must be known for biodosimetric reconstruction of radiation dose to an individual: (1) the measured frequency in the individual (Yi), (2) the background frequency (Yb), and (3) the slope (a) of the calibration curve (Eqn. 1). Under such conditions, uncertainties in these three parameters will determine the overall uncertainty in the dose estimate.

D = (Yi - Yb) / a (1)

We have already measured "a" for some radiations. We are now measuring the Yb in equation (1) for unexposed people.

Methodology: Peripheral blood samples (~5ml) will be taken from volunteers or during routine medical examination, cultured, and the lymphocytes spread onto glass slides for analysis of chromosome aberration frequencies. The principal method for measuring chromosome aberrations will involve chromosome painting technology.