USDOE Human Subjects Research Database, fiscal year 1995

Lawrence Berkeley National Laboratory

Project Identifier: LBNL-93-114-H01

Project Title:

The Development of Automatic Three-Dimensional Microscopic Imaging of Fluorescent Stained Clinical Specimens (see LBL-93-12-59 in 1994 database)

Principle Investigator: Dr. Stephen J. Lockett

Project started in: 1993

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:

Non-Federal: Whitaker Foundation

Amount: $6,000 (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: June 05, 1995
IRB Approval Number: 95-1-54

Number of Human Subjects in the Last Reporting Period for this Project: 20
(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 existing bodily materials that were collected for another purpose or project.

Questionnaires, Surveys, Epidemiological Studies:

Use of personally identifiable data from questionnaires, surveys, or epidemiological studies.

• Use of existing data 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])

OBJECTIVES

The objective of this study is to develop techniques and instrumentation to automatically identify specific molecules associated with cancer in human breast tissue specimens. This study will aid in the development of diagnostic tools and case management for patients with breast cancer.

METHODOLOGY

The specimens are derived from tissue discarded following pathological examination. The samples are then examined using molecular, biological, and optical microscopic techniques. The results are evaluated in relation to information from the patient's medical record.

INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS

Because the specimens are collected at another site for another purpose, this study poses no additional risk to human subjects.