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Clinical Trials Search at Vanderbilt-Ingram Cancer Center

A Study to Compare Two Surgical Procedures in Women with BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer

This trial studies how well two surgical procedures (bilateral salpingectomy and bilateral salpingo-oophorectomy) work in reducing the risk of ovarian cancer for women 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.
Ovarian
N/A
Adults
Not Available
Not Available
Brown, Alaina
International
Vanderbilt University
11-09-2021
Prevention
NRGGYNCC008
NCT04251052

Eligibility

35 Years
FEMALE
NO
Inclusion Criteria:

Women 35-50 years of age, inclusive

Patients who have declined or elected to defer risk-reducing salpingo-oophorectomy (RRSO) after proper counselling to clearly explain the standard of care for BRCA1 mutation carriers (for the BLS with delayed oophorectomy arms) or patients who are undergoing RRSO (for the RRSO arm)

At least one intact ovary and fallopian tube is in situ at the time of counseling and consent. Prior hysterectomy is allowed provided it did not include bilateral salpingectomy. Prior tubal ligation is allowed if one intact ovary and tube are present

Positive Clinical Laboratory Improvement Act (CLIA)-approved test results for pathogenic or likely pathogenic germline BRCA1 mutation in the patient herself. Documentation of the result is required

Premenopausal; defined as = 12 months of amenorrhea who may be pre-menopausal or patients with a prior hysterectomy with at least one retained ovary/tube, levels of follicle stimulating hormone (FSH), luteinizing hormone (LH), and in the premenopausal range per local institutional standards will be acceptable. Concurrently planned hysterectomy with salpingectomy for the BS group or with BSO for the BSO group is permitted

Transvaginal ultrasound (TVUS) and CA-125 within 180 days of registration

The patient or a legally authorized representative must provide study-specific informed consent prior to study entry



Exclusion Criteria:

Women with a history of any prior cancer who have received chemotherapy within the past 12 months, hormonal therapy in the past 90 days, or radiotherapy to abdomen or pelvis at any prior time

Prior history of ovarian cancer, including low malignant potential neoplasms (LMP), primary peritoneal carcinoma, or fallopian tube carcinoma

Patients medically unfit for the planned surgical procedure

Patients with abnormal screening tests (TVUS, CA-125) suspicious for occult or gross pelvic malignancy or neoplasm within the past 180 days * An abnormal TVUS is defined as morphologic or structural variations suspicious for ovarian malignancy or complex cystic lesions (simple cysts 50 U/ml in this study population of premenopausal women if they are not current users of oral contraceptives; an abnormal CA-125 is defined as a level > 40 U/ml for premenopausal women who are current users of oral contraceptives

Women who are currently pregnant or plan to become pregnant in the future

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