The Center for Medical Genetics in association with the NorthShore University HealthSystem Division of Gynecologic Oncology conducts early detection and prevention studies in the area of ovarian cancer.
Clinical Ovarian Cancer Research:
GOG-0199 Prospective Study of Risk-Reducing Salpingo-oophorectomy and Longitudinal CA-125 Screening Among Women at Increased Genetic Risk of Ovarian Cancer
This is an international study of women at high risk of ovarian cancer due to family history and/or genetic status.
Investigators
Principal Investigator: Gustavo Rodriguez, MD
Co-Investigators: Wendy S. Rubinstein, MD, PhD
Capsule
We are following a group of women over time to better understand the incidence of ovarian cancer, breast cancer, primary peritoneal carcinoma (an ovarian-like cancer), and all cancer in women at increased risk of ovarian cancer. We are placing special emphasis on women who are known BRCA1/2 mutation carriers.
In addition, we plan to determine the prevalence of undetected ovarian cancer and fallopian tube cancer among women undergoing prophylactic salpingo-oophorectomy (removal of the fallopian tubes and ovaries). We are looking at changes in quality of life issues over time by comparing women undergoing screening and women who have undergone salpingo-oophorectomy. We recruited more subjects than any of the 124 international sites; our enrollment accounted for about 9% of study accrual.
Study accrual is complete as of November 2006; 2,605 participants enrolled: 1,030 (40%) into the surgical cohort and 1,575 (60%) into the screening cohort. Five years of prospective follow-up ends in November 2011. Verification of BRCA mutation carrier status is under way, either through patient-provided reports from clinical genetic testing done before enrollment or through research-based genetic testing being conducted as part of the protocol. Patient eligibility is currently under evaluation and baseline, surgical, pathology, and outcome data are still being collected.
Study Participant Recruitment & Eligibility
Recruitment closed
Publications
Menon U. Skates SJ. Lewis S. Rosenthal AN. Rufford B. Sibley K. Macdonald N. Dawnay A. Jeyarajah A. Bast RC Jr. Oram D. Jacobs IJ. Prospective study using the risk of ovarian cancer algorithm to screen for ovarian cancer. Journal of Clinical Oncology. 23(31):7919-26, 2005.
Greene MH. Piedmonte M. Alberts D. Gail M. Hensley M. Miner Z. Mai PL. Loud J. Rodriguez G. Basil J. Boggess J. Schwartz PE. Kelley JL. Wakeley KE. Minasian L. Skates S. A prospective study of risk-reducing salpingo-oophorectomy and longitudinal CA-125 screening among women at increased genetic risk of ovarian cancer: design and baseline characteristics: a Gynecologic Oncology Group study. Cancer Epidemiology, Biomarkers & Prevention. 17(3):594-604, 2008.
Ovarian Cancer Prevention:
Population-based genetic testing for BRCA1/2 in an Ashkenazi Jewish population
We performed an analysis to investigate the effect of a genetic screening program on ovarian cancer occurrence, life expectancy and public health costs.
Investigators
Principal Investigator: Wendy S. Rubinstein, MD, PhD
Co-Investigators: Hongmei Jiang, PhD; Lisa Dellefave, MS; Alfred W. Rademaker, PhD
Capsule
BRCA1/2 mutation carriers face a high lifetime risk of developing breast and/or ovarian cancer. When a woman knows of her carrier status in advance, she can pursue either high-risk screening, chemoprevention or risk-reducing surgery for breast and ovarian cancer. Most carriers are detected based on a strong family history of cancer; however, some individuals may have small families, few female relatives, or lack knowledge of their family history. Prior studies indicate that about half of BRCA1/2 carriers may not be identifiable by family history criteria. A population-based screening program could identify the carrier status of such family history-negative individuals. This could be the only opportunity to identify such individuals before they develop cancer so that they may avail themselves of early detection and prevention options.
The purpose of the study was to estimate the number of ovarian cancer diagnoses that would be prevented, the life expectancy gained, and the public health costs by implementing a population-based screening program for genetic testing of BRCA1/2 in the U.S. Ashkenazi Jewish population.
Outcomes
Our analysis determined that a population-screening program of Ashkenazi Jewish women in the U.S. would result in 2811 fewer cases of ovarian cancer, improved life expectancy, and would be cost-effective when compared to recommended public health interventions such as mammographic screening. We called for a dialogue among Jewish stakeholders, genetics professionals, and public health leaders to determine whether a population-based screening program should be pursued.
Publication
Rubinstein WS, Jiang H, Dellefave L, Rademaker AW. Cost-effectiveness of population-based BRCA1/2 testing and ovarian cancer prevention for Ashkenazi Jews: A call for dialogue. Genetics in Medicine. 2009; 11(9):629-639.