Author: Christopher Darus, M.D., MS, medical director, Providence Gynecologic Oncology Program
Everyone has BRCA1 and BRCA2 genes, which are responsible for DNA repair, and to 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 nonrandomized clinical trial at Providence Cancer Institute currently is 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.
Clinical trial eligibility
This interventional clinical trial is estimated to enroll 2,250 patients across several U.S. states. 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.
Details about the SOROC study
The goal of this study is to prevent ovarian cancer while also preventing the onset of early menopause through ovary removal. 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.
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
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.
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)
For more information or to enroll a patient, call our clinical research office at 503-215-2614 or submit a referral form.
Educational event for gynecologic cancer patients
Providence Cancer Institute and the Ovarian Cancer Alliance of Oregon & SW Washington present “Coping with Chemotherapy,” a free, virtual patient education event on March 9, 2022.
Gynecologic cancer patients and their caregivers will learn how to participate in their own health care by learning about chemotherapy and its side effects, both physically and emotionally.
Topics will include:
- Taking an active role in care
- Understanding chemotherapy
- Most common types of chemotherapy, including immunotherapy and oral PARP inhibitors
- Understanding and managing the side effects of chemotherapy
- Communicating with health care teams
To learn more and register for the event, visit our website.
Our team of gynecologic cancer specialists
The Providence Gynecologic Oncology Program provides specialized care for patients with suspected or known gynecologic malignancies and complex precancerous conditions. Through the program, patients have access to advanced treatments, such as robotic surgery, immunotherapy, and the latest research and clinical trials. Patients also have the convenience of receiving all their care under one roof.
In addition to our providers, members of the team include oncology nurses, radiation oncologists, gynecologic pathologists, genetic risk experts, oncology social workers, integrative medicine providers, nutrition specialists, clinical trials nurses, medical assistants and others.
Learn more
- See all gynecologic cancer studies and multi-indication trials.
- Visit our website to view studies for all types of cancer.
- View Dr. Darus’s provider profile.
- Visit Providence Gynecologic Oncology Program.
About the Author
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