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]
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- NRG Oncology
- 入组人数
- 1,956
- 试验地点
- 842
- 主要终点
- Time to development of incident high-grade serous carcinomas (HGSC), specifically ovarian, primary peritoneal, or fallopian tube cancers
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Group I (bilateral salpingectomy)
Patients undergo bilateral salpingectomy. Patients may then undergo oophorectomy after initial surgery. Patients also undergo a pelvic or transvaginal ultrasound or pelvic MRI during screening and blood sample collection throughout the trial.
干预措施: Ultrasound Imaging (Procedure)
Group II (bilateral salpingo-oophorectomy)
Patients undergo bilateral salpingo-oophorectomy. Patients also undergo a pelvic or transvaginal ultrasound or pelvic MRI during screening and blood sample collection throughout the trial.
干预措施: Bilateral Salpingectomy with Oophorectomy (Procedure)
Group II (bilateral salpingo-oophorectomy)
Patients undergo bilateral salpingo-oophorectomy. Patients also undergo a pelvic or transvaginal ultrasound or pelvic MRI during screening and blood sample collection throughout the trial.
干预措施: Biospecimen Collection (Procedure)
Group II (bilateral salpingo-oophorectomy)
Patients undergo bilateral salpingo-oophorectomy. Patients also undergo a pelvic or transvaginal ultrasound or pelvic MRI during screening and blood sample collection throughout the trial.
干预措施: Questionnaire Administration (Other)
Group II (bilateral salpingo-oophorectomy)
Patients undergo bilateral salpingo-oophorectomy. Patients also undergo a pelvic or transvaginal ultrasound or pelvic MRI during screening and blood sample collection throughout the trial.
干预措施: Transvaginal Ultrasound (Procedure)
Group I (bilateral salpingectomy)
Patients undergo bilateral salpingectomy. Patients may then undergo oophorectomy after initial surgery. Patients also undergo a pelvic or transvaginal ultrasound or pelvic MRI during screening and blood sample collection throughout the trial.
干预措施: Bilateral Salpingectomy (Procedure)
Group I (bilateral salpingectomy)
Patients undergo bilateral salpingectomy. Patients may then undergo oophorectomy after initial surgery. Patients also undergo a pelvic or transvaginal ultrasound or pelvic MRI during screening and blood sample collection throughout the trial.
干预措施: Biospecimen Collection (Procedure)
Group I (bilateral salpingectomy)
Patients undergo bilateral salpingectomy. Patients may then undergo oophorectomy after initial surgery. Patients also undergo a pelvic or transvaginal ultrasound or pelvic MRI during screening and blood sample collection throughout the trial.
干预措施: Magnetic Resonance Imaging (Procedure)
Group I (bilateral salpingectomy)
Patients undergo bilateral salpingectomy. Patients may then undergo oophorectomy after initial surgery. Patients also undergo a pelvic or transvaginal ultrasound or pelvic MRI during screening and blood sample collection throughout the trial.
干预措施: Quality-of-Life Assessment (Other)
Group I (bilateral salpingectomy)
Patients undergo bilateral salpingectomy. Patients may then undergo oophorectomy after initial surgery. Patients also undergo a pelvic or transvaginal ultrasound or pelvic MRI during screening and blood sample collection throughout the trial.
干预措施: Questionnaire Administration (Other)
Group I (bilateral salpingectomy)
Patients undergo bilateral salpingectomy. Patients may then undergo oophorectomy after initial surgery. Patients also undergo a pelvic or transvaginal ultrasound or pelvic MRI during screening and blood sample collection throughout the trial.
干预措施: Transvaginal Ultrasound (Procedure)
Group II (bilateral salpingo-oophorectomy)
Patients undergo bilateral salpingo-oophorectomy. Patients also undergo a pelvic or transvaginal ultrasound or pelvic MRI during screening and blood sample collection throughout the trial.
干预措施: Magnetic Resonance Imaging (Procedure)
Group II (bilateral salpingo-oophorectomy)
Patients undergo bilateral salpingo-oophorectomy. Patients also undergo a pelvic or transvaginal ultrasound or pelvic MRI during screening and blood sample collection throughout the trial.
干预措施: Quality-of-Life Assessment (Other)
Group II (bilateral salpingo-oophorectomy)
Patients undergo bilateral salpingo-oophorectomy. Patients also undergo a pelvic or transvaginal ultrasound or pelvic MRI during screening and blood sample collection throughout the trial.
干预措施: Ultrasound Imaging (Procedure)
结局指标
主要结局
Time to development of incident high-grade serous carcinomas (HGSC), specifically ovarian, primary peritoneal, or fallopian tube cancers
时间窗: Up to 20 years
Will be assessed using a stratified log rank test, stratifying for age. The effects of other covariates, such as familial history of gynecologic cancer, time to crossover for bilateral salpingectomy (BLS) patients, and age at study entry, will be adjusted for in Cox proportional hazard models. Patients who crossover will be analyzed according to the initial surgery received at study enrollment as this will reflect actual practice.
次要结局
- Health-related quality of life (QOL)(Up to 24 months post-surgery)
- Cancer distress(Up to 24 months post-surgery)
- Medical decision making(Up to 24 months post-surgery)
- Incidence of adverse events(Up to 20 years)
- Estrogen deprivation symptoms (pre-menopaused patients only)(Up to 24 months post-surgery)
- Sexual dysfunction (pre-menopausal patients only)(Up to 24 months post-surgery)
- Menopausal symptoms (pre-menopausal patients only)(Up to 24 months post-surgery)
- Health-related quality of life (QOL)(Up to 24 months post-surgery)
- Cancer distress(Up to 24 months post-surgery)
- Medical decision making(Up to 24 months post-surgery)
- Incidence of adverse events(Up to 20 years)
- Estrogen deprivation symptoms (pre-menopaused patients only)(Up to 24 months post-surgery)
- Sexual dysfunction (pre-menopausal patients only)(Up to 24 months post-surgery)
- Menopausal symptoms (pre-menopausal patients only)(Up to 24 months post-surgery)