NRG-CC008: A Non-Randomized Prospective Clinical Trial Comparing the Non-Inferiority of Salpingectomy to Salpingo-Oophorectomy to Reduce the Risk of Ovarian Cancer Among BRCA1 Carriers [SOROCk] (SOROCk- NRG-CC008)

Surgical Options to Lower Ovarian Cancer Risk in BRCA1 Carriers

Enrolling By Invitation
35 years - 50 years
Female
Phase N/A
1956 participants needed
1 Location

Brief description of study

This clinical trial evaluates how well two 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.

Detailed description of study

PRIMARY OBJECTIVE:

I. To compare the non-inferiority of bilateral salpingectomy (BLS) with delayed oophorectomy to bilateral salpingo-oophorectomy (BSO) to reduce the risk of ovarian cancer among individuals with deleterious BRCA1 germline mutations.

SECONDARY OBJECTIVES:

I. To prospectively assess estrogen deprivation symptoms in pre-menopausal BLS patients as measured by the Functional Assessment of Cancer Therapy - Endocrine Symptom (FACT-ES) subscale compared to pre-menopausal patients in the BSO arm.

II. To determine if health-related quality of life (QOL) (FACT) is negatively impacted by menopausal symptoms (menopausal symptom checklist-Menopausal Symptom Checklist [MSCL]) and sexual dysfunction (Female Sexual Function Index [FSFI]) in pre-menopausal patients who have undergone BLS, in comparison to normative data (MSCL/FACT-ES) and data from pre-menopausal BSO patients.

III. To determine if health-related QOL (FACT) is negatively impacted by cancer distress (Impact of Event Scale [IES]) in individuals who have undergone BLS, in comparison to BSO patients.

IV. To assess medical decision making, as measured by the Shared Decision Making Questionnaire (SDM-Q-9) and Decision Regret Scale (DRS), and determine factors associated with the risk of reducing surgical treatment choice.

V. To assess adverse events, graded using Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0.

EXPLORATORY OBJECTIVES:

I. Sexual dysfunction, as measured by selected Patient-Reported Outcomes Measurement Information System (PROMIS) screener and external sexual function items (pre-menopausal patients).

II. To estimate the cost-effectiveness of BLS compared to BSO for ovarian cancer risk reduction.

III. To assess medical decision making, as measured by the Risk-Reducing Medical Decision Making (RR-MDM) survey, a targeted set of questions on risk reducing surgical treatment choice.

TRANSLATIONAL RESEARCH OBJECTIVE:

I. To bank tissue and blood biospecimens for future research.

OUTLINE: Patients choose between 1 of 2 groups.

GROUP I: Patients undergo bilateral salpingectomy. Patients may then undergo oophorectomy after initial surgery.

GROUP II: Patients undergo bilateral salpingo-oophorectomy.

Patients in both groups also undergo a pelvic or transvaginal ultrasound or pelvic magnetic resonance imaging (MRI) during screening and blood sample collection throughout the trial.

After completion of study, patients are followed up at 10-60 days, 6, 12, and 24 months, and then annually for up to 20 years.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Ovarian Carcinoma
  • Age: 35 years - 50 years
  • Gender: Female

Inclusion Criteria:

  • Individuals 35-50 years of age, inclusive
  • Patients who will undergo risk-reducing salpingo-oophorectomy (RRSO) (for the BSO arm) and patients who have declined or elected to defer BSO after proper counselling to clearly explain the standard of care for BRCA1 mutation carriers and are undergoing salpingectomy (for the BLS arm with delayed oophorectomy arm). Concurrently planned hysterectomy with either arm is permitted
  • At least one intact ovary and fallopian tube is in situ at the time of counseling, consent, and registration. Prior hysterectomy is allowed provided it did not include bilateral salpingectomy. Prior tubal ligation is allowed if one ovary and fallopian tube (with fimbria not removed) are present
  • Positive Clinical Laboratory Improvement Act (CLIA)-approved test results for pathogenic or likely pathogenic germline BRCA1 mutation in the patient. Documentation of the result is required
  • Patients may be premenopausal or menopausal
  • Pelvic ultrasound (transvaginal imaging preferred, but transabdominal imaging is acceptable) or pelvic MRI 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
  • Individuals who are currently pregnant or plan to become pregnant in the future through assisted reproductive technologies and who have received proper counseling are eligible. Individuals who are currently pregnant and plan bilateral salpingectomy at the time of a planned cesarean section are eligible. Patients must understand that they will not be able to become pregnant naturally in the future

Exclusion Criteria:

  • Individuals with a history of any prior cancer who have received cytotoxic chemotherapy within the past 30 days or radiotherapy to abdomen or pelvis at any prior time. Endocrine therapy or maintenance ERBB2/HER2 targeted therapy is allowed. Maintenance immune checkpoint inhibitor therapy is allowed. Maintenance therapy with PARP in inhibitor is allowed.
  • 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 (pelvic ultrasound, pelvic MRI, CA-125) suspicious for occult or gross pelvic malignancy within the past 180 days
    • An abnormal pelvic ultrasound (or pelvic MRI) is defined as morphologic or structural variations suspicious for ovarian malignancy. Complex cystic lesions felt to represent a benign lesion are not exclusionary. Simple cysts of any size are not exclusionary
    • An abnormal CA-125 is defined as a level > 50U/ml in premenopausal individuals if they are not current users of oral contraceptives; an abnormal CA-125 is defined as a level > 40U/ml for premenopausal individuals who are current users of oral contraceptives (Skates 2011). An abnormal CA-125 is defined as a level > 35 U/ml in postmenopausal individuals

This study investigates the effectiveness of two surgical procedures in reducing the risk of ovarian cancer in individuals with BRCA1 mutations. The purpose of this study is to compare bilateral salpingectomy, which involves removing the fallopian tubes, with bilateral salpingo-oophorectomy, which involves removing both the fallopian tubes and ovaries. These procedures are being evaluated to determine their ability to lower ovarian cancer risk in individuals with BRCA1 mutations.

Participants in the study will either undergo bilateral salpingectomy or bilateral salpingo-oophorectomy. After the surgery, they will also have a pelvic or transvaginal ultrasound or pelvic MRI and provide blood samples throughout the trial. The study will assess various factors like estrogen deprivation symptoms, quality of life, and medical decision-making processes. Participants will be followed up at specified intervals to monitor outcomes.

  • Who can participate: Individuals aged 35 to 50 with a confirmed BRCA1 mutation and at least one intact ovary and fallopian tube are eligible. They must be able to provide informed consent, and pregnant individuals planning a bilateral salpingectomy during a cesarean section can also join.
  • Study details: Participants will choose between bilateral salpingectomy or bilateral salpingo-oophorectomy. They will have imaging tests and give blood samples, and the study will assess their quality of life and medical decision-making.
Updated on 25 Aug 2026. Study ID: 21-0352
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