Spring 2003

Study Update: The Risk of Ovarian Cancer Algorithm (ROCA) Study

http://epi.grants.cancer.gov/ovarian/

Since the summer of 2001, many of the women enrolled in the MACGN have taken part in a nationwide ovarian cancer screening study sponsored by the National Cancer Institute. Investigators with the ROCA study hope to determine the effectiveness of measuring CA125 for the early detection of ovarian cancer. CA125 is a protein. It is used as a biomarker of ovarian cancer and can be found with a simple blood test.

Because ovarian cancer is often found late when treatment is difficult, researchers want to find a method to screen for ovarian cancer before symptoms develop. Since the CA125 level is elevated in 80-85% of women with advanced ovarian cancer, scientists are hoping to establish normal ranges of CA125 for high-risk women along with confirming the sensitivity and specificity of the biomarker test.

The study is comprised of women at high risk for developing ovarian cancer. Participants must be 30 years of age or older with a strong family history of ovarian cancer and/or breast cancer. Women with a mutation in the BRCA1 or BRCA2 gene are also eligible for this study.

To join the ROCA study, a participant will complete a questionnaire about her personal health at the first visit. At each follow-up visit women complete a very brief survey about their health since the last visit. A blood sample (about two tablespoons) is also drawn at each visit.. Study staff will continue to meet with participants every three months until the fall of 2003. With successful funding, this pilot project will develop into a five-year trial after September 2003 with women participating as long as they would like.

To date over 100 women have enrolled in the study from the Hopkins site alone. Our recruitment goal is 200 women. Nationwide, over 1000 women are taking part in this important research study.

Study personnel meet with study participants at various locations on and off the Johns Hopkins medical campus. We also send blood kits and questionnaires to eligible women who are unable to travel to Baltimore.

Although most participants have previously enrolled in the MACGN registry, we also recruit from the Breast and Ovarian Surveillance Service (BOSS) at Johns Hopkins and from eligible patients at Greater Baltimore Medical Center. If you would like to talk with us about joining this study, or you know someone who may qualify please call us at 410-502-7660 or toll-free at 887-880-6188.

If you are already part of our study, thank you very much for your contribution to the success of this research. Your participation is crucial.

Written by: Judy Bacon, B.S., Research Project Coordinator