NRG-CC008

Summary

This clinical trial evaluates how well 2 surgical procedures (bilateral salpingectomy and bilateral salpingo-oophorectomy) work in reducing the risk of ovarian cancer for individuals with BRCA1 mutations. Bilateral salpingectomy involves the surgical removal of fallopian tubes, and bilateral salpingo-oophorectomy involves the surgical removal of both the fallopian tubes and ovaries. This study may help doctors determine if the two surgical procedures are nearly the same for ovarian cancer risk reduction for women with BRCA1 mutations.

To be included in NRG-CC008, participants must be / have

• Women 35 – 50 years of age.
• At least one intact ovary and fallopian tube is in situ at the time of counseling and consent. Prior hysterectomy only is allowed; prior tubal ligation is allowed if one intact ovary and tube are present.
• Positive CLIA-approved test results for pathogenic or likely pathogenic germline BRCA1 mutation in the patient herself.
• Transvaginal ultrasound and CA-125 within 180 days of registration.

To be included in NRG-CC008, participants must not be / have

• Women with a history of any prior cancer who have received chemotherapy within the past 12 months, hormonal therapy within the past 90 days, or radiotherapy to the abdomen or pelvis at any prior time
• Prior history of ovarian cancer, including low malignant potential neoplasms, primary peritoneal carcinoma, or fallopian tube carcinoma
• Patients medically deemed unfit for the planned surgical procedure
• Patients with an abnormal transvaginal ultrasound or CA-125 that is suspicious for occult or gross pelvic malignancy or neoplasm within the past 180 days
• Women who are currently pregnant or plan to become pregnant in the future

Keywords

Ovarian cancer; Surgery