Clinical trial aims to help premenopausal women at risk for ovarian cancer
Everyone has BRCA1 and BRCA2 genes, which are responsible for DNA repair, and help protect you from getting certain cancers. But an inherited mutation of BRCA1 and BRCA2 prevents the genes from working properly and may increase the risk of some cancers. For example, lifetime risks for breast and ovarian cancers are significantly increased by an inherited gene mutation. A BRCA1 mutation may increase ovarian cancer risk in women by as much as 44 % by age 80.
Currently, a woman with a family history of ovarian cancer can receive a genetic test to detect BRCA1 and BRCA2 gene mutations. If a mutation is identified she may choose surgical intervention to help reduce her ovarian cancer risk.
A non-randomized clinical trial at the Earle A. Chiles Research Institute, a division of Providence Cancer Institute in Portland, Oregon, is currently studying how well two surgical procedures – bilateral salpingectomy and bilateral salpingo-oophorectomy – work in reducing the risk of ovarian cancer for women with BRCA1 mutations. The study is supported by the National Cancer Institute.
A bilateral salpingectomy removes both fallopian tubes and a bilateral salpingo-oophorectomy removes the fallopian tubes and ovaries. Recent studies suggest that many ovarian cancers form in the cells of the fallopian tube before spreading to the ovary where they continue to grow. Removing the fallopian tubes could eliminate the source and interrupt the spread of potentially cancerous cells to the ovary.
The study includes two arms:
- Experimental Group I – A bilateral salpingectomy surgical procedure (with possible oophorectomy after initial surgery)
- Active Comparator, Group II – A bilateral salpingo-oophorectomy
“The goal of this study is to prevent ovarian cancer while also preventing the onset of early menopause through ovary removal,” says Christopher J. Darus, M.D., the study investigator for Providence in Oregon. Results of this study could help doctors determine a treatment path for premenopausal women with BRCA1 mutations that reduces cancer risk and supports the highest quality of life.
Dr. Darus is medical director of the Gynecologic Cancer Program at Providence Cancer Institute in Oregon. He is an active member of the Society of Gynecologic Oncology and other leading medical associations dedicated to advancing research, treatment, and prevention of gynecologic cancers.
Full details of the study are available here:
Who can participate?
The following factors determine a participant’s eligibility in the study:
- Patient must have at least one intact ovary and fallopian tube.
- Patient must be 35 to 50 years of age.
- Patient must not have prior history of ovarian cancer, including low malignant potential neoplasms (LMP), primary peritoneal carcinoma, or fallopian tube carcinoma.
- Concurrently planned or prior hysterectomy is permitted if at least one fallopian tube and one ovary were retained.
Outcome measures provide a score or interpretation of a study, as well as a baseline for interpreting data.
The primary outcome measure for this study provides:
- Time to development of incident high-grade serous carcinomas, specifically ovarian, primary peritoneal, or fallopian tube cancers.
Secondary outcome measures (up to 24 months post-surgery) include:
- Health-related quality of life
- Sexual dysfunction
- Menopausal symptoms
- Cancer distress
- Estrogen deprivation symptoms
- Medical decision-making
- Incidence of adverse events (up to 20 years)
See more studies
This study is one of several gynecologic cancer studies currently open to enrollment at Providence Cancer Institute in Oregon. New research studies are added frequently. Visit our website to view all open studies in all cancer types.
The Providence Gynecologic Cancer Program provides highly specialized care for patients diagnosed with ovarian, cervical, uterine, vaginal, vulvar and other female reproductive tract cancers, as well as pre-cancerous conditions. Patients receive advanced treatments, from robotic surgery to immunotherapy, with the opportunity to participate in clinical trials
For more information or to refer patients to this study, please contact our Clinical Research office: