USDOE Human Subjects Research Database, Fiscal Year 2004

Yale University

Public Information Contact:

Dr. David C. Ward
333 Cedar St, SHM I-157
New Haven, CT 06510

Phone: 203-785-2683
Fax: 203-785-7023
E-mail: david.ward@yale.edu

Institutional Review Board (IRB):

Human Subject Projects:

Number of Human Subjects projects reported: 1

YU-02-ER63462

"Serum Protein Profiling Using Proteomic Arrays and Mass Spectrometry: Identification of Non-Invasive Biomarkers for Prostate, Ovarian, and Lung Cancers."

Project Identifier: YU-02-ER63462

"Serum Protein Profiling Using Proteomic Arrays and Mass Spectrometry: Identification of Non-Invasive Biomarkers for Prostate, Ovarian, and Lung Cancers."

Principal Investigator: Dr. David C. Ward, Yale University

Project started in: 2002
This project ended in fiscal year 2004.

Project Funding Information:

Funding for Human Subjects Research:

DOE: Office of Biological and Environmental Research (OBER)

$150,000.00 (Est.) for: Fiscal Year 2004
continuation of funding for this fiscal year.

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: Yale University
Most recent approval: 10/21/03
IRB approval number: 10425
Explanation of IRB approval:
This is the most recent official update

Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 206
Reporting period for number of human subjects: Fiscal Year 2004

Type(s) of Human Subjects Involvement:

Collection of personally identifiable bodily materials (blood or blood products, urine, cells, tissue, teeth, organs, excreta, etc):

• Using existing specimens or samples of bodily materials collected for another purpose.

(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])

Three main objectives of this study include: (1) Determine what are the molecular properties that characterize the Fas-apoptotic pathway in normal ovarian tissue; (2) Study the molecular features of this apoptotic system in ovarian cancer; and (3) Use these molecules for therapeutic approaches. Samples of primary and metastatic cancer and normal endometrium, myometrium, ovarian, and placenta tissues are obtained at the time of surgery or delivery.

These tissues will be subject to RT-PCR, western blot analysis, and other molecular techniques to determine the expression of the components of the Fas-apoptotic pathway. [RT-PCR refers to reverse transcription of RNA to DNA (mRNA to cDNA), followed by polymerase chain reaction to amplify specific seaquences.] Normal tissues from ovary and placenta are used to prepare primary cultures. Humans are not exposed to ionizing radiation, radioactive substances, or chemical substances as part of this protocol.

This protocol presents minimal risks (no risk) to the subjects and adverse events are not anticipated. In the unlikely event that such events occur, serious unanticipated adverse events will be reported within 48 hours to the Yale Human Investigations Committee (using HIC form 6A) and any appropriate funding and regulatory agencies. The principal investigator (PI) will specify whether the serious unanticipated adverse event is considered related to the study. Access to data will be restricted to the PI. Patients will not be identified by name or any other personal identifying information in any report or publication resulting from this study.