USDOE Human Subjects Research Database, fiscal year 1995

Lawrence Livermore National Laboratory

Project Identifier: LLNL-95-121

Project Title:

Chromosome Painting: Chemical Clastogens

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 did not use human subjects in Fiscal Year 1995.

Explanation:

Project used archived slides of human blood lymphocytes.

Funding Sources:

DOE: DOE/Energy Research

Amount: $100,000 (Est.)

Non-DOE Federal: NIH-Epidemiology

Amount: $120,000 (Est.)

Total Funding: $220,000

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: 95-121

Number of Human Subjects in the Last Reporting Period for this Project: 40
(Reporting periods vary.)

Type of Human Subjects Involvement:

Chemical Substances:

External use of chemical substances (solid, liquid, or gas) on human subjects.

• Other external use of chemical substances:

  Accidental exposure to Benzene in work place.

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])

Archived slides containing spreads of fixed human lymphocytes from 40 individuals exposed to Benzene will be sent to LLNL for chromosomal translocation analysis using FISH.

The objectives of this project are: (1) To determine the feasibility of performing FISH on these archived materials and (2) to support the epidemiology studies conducted by NIH on these individuals. If (1) is successful, it will facilitate retrospective dosimetry of chemical exposure to individuals where slides have been prepared in the distant past. These results can be directly compared to cancer rates of those individuals from NIH epidemiology studies. If (2) is successful, NIH will be able to obtain biological doses to support their on-going epidemiology studies.

Methodology: (1) Archived slides containing metaphase spreads of fixed human lymphocytes obtained from 40 individuals will be evaluated to determine if FISH can be successfully performed on any of them. FISH will be applied to the slides using established standard protocol. (2) If FISH is successful, those slides will then be subjected to translocation analysis using chromosome painting to compare benzene exposure with chromosome translocation frequencies. (3) The procedure will then be given to NIH which will use it to measure translocation frequencies in support of on-going epidemiology (past benzene exposure) studies.

No human subjects are currently involved. All materials are archived slides of human metaphase spreads.