Prophylactic Salpingectomy With Delayed Oophorectomy, Risk-Reducing Salpingo-Oophorectomy, and Ovarian Cancer Screening Among BRCA Mutation Carriers: A Proof-of-Concept Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- Patient Compliance with Prophylactic Salpingectomy with Delayed Oophorectomy Strategy
研究概览
简要总结
The goal of this clinical research study is to compare ovarian cancer screening, risk-reducing salpingo-oophorectomy (RRSO), and prophylactic salpingectomy with delayed oophorectomy (PSDO). The safety of RRSO and PSDO will also be studied.
Ovarian cancer screening does not involve a surgical procedure. Instead, physical exams, blood tests, and ultrasound are used to check for ovarian, fallopian tube, and peritoneal cancer.
The surgical procedures, RRSO and PSDO, are designed to lower your risk of ovarian cancer.
In RRSO, the fallopian tubes and ovaries are removed at the same time.
In PSDO, the fallopian tubes are removed and the ovaries remain in place so that the patient does not go through menopause. The ovaries are removed at a later date. The main goal of this study is to learn how many patients actually have their ovaries removed at a later date. Researchers also want to learn whether the removal of fallopian tubes will decrease the risk of ovarian cancer.
详细描述
This study has 3 options: ovarian cancer screening, PSDO, and RRSO. You may choose which study group you want to take part in. However, you must let the researchers know what your choice is before any testing for the study begins. The 3 study groups are described in detail below.
GROUP 1: OVARIAN CANCER SCREENING:
Study Visits:
For this group, there is no testing required before starting the study. If you agree to be in Group 1, the following tests and procedures will be performed:
- You will have a physical exam, including a pelvic exam.
- You will have a transvaginal ultrasound (ultrasound inside the vagina) to look at your ovaries and fallopian tubes.
- Blood (about 2 tablespoons) will be drawn to measure your CA125 levels. This test is used to screen for ovarian cancer.
- You will complete a questionnaire about your quality of life. This should take up to 15 minutes.
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
- 30 Years 至 47 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Premenopausal women with a documented BRCA1 or BRCA2 mutation. Menopause is defined as >/= 12 months of amenorrhea.
- •Women must be at least 30 and less than 48 years of age.
- •Candidate for surgery and willing to undergo two surgical procedures (if chooses the PSDO arm).
- •Patient choosing PSDO or RRSO must desire permanent sterilization.
- •Presence of at least one fallopian tube. Prior tubal ligation is allowed.
- •Participants may have a personal history of non-ovarian malignancy, but must be without evidence of disease at enrollment and the patient must have completed treatment (including surgery, chemotherapy, or radiotherapy) > 3 months prior to enrollment (other than non-melanoma skin cancer). Current or past SERM or aromatase inhibitor use is allowed.
- •Willingness to return to the enrolling site for any surgical procedures including pre-operative and post-operative care.
- •Willingness to return to the enrolling site for ovarian cancer screening during the study period.
排除标准
- •Postmenopausal women or women < 30 or >/= 48 years of age.
- •Women without a documented BRCA mutation.
- •Women with a history of ovarian, fallopian tube, or primary peritoneal cancer.
- •Women currently undergoing cancer treatment or with a known active cancer. History of malignancy is allowed as long as the patient has completed treatment > 3 months prior to enrollment.
- •Medical comorbidities making surgery unsafe as determined by the patient's surgeon.
- •Prior bilateral salpingectomy. Prior unilateral salpingectomy is allowed.
- •Women who are pregnant. Patients are deemed not pregnant by virtue of urine pregnancy test (UPT), transvaginal ultrasound, beta HCG, or best judgement of the investigator. Pregnancy testing is not required per protocol to determine study eligibility.
- •Women desiring future fertility except in the screening arm of the trial.
- •Women whose most recent CA125 or transvaginal ultrasound is abnormal. A history of abnormal CA125 or ultrasound is allowed, as long as the most recent testing is normal.
- •Inability to provide informed consent.
- •Inability to read or speak English.
研究组 & 干预措施
Ovarian Cancer Screening
Woman who have a mutation (genetic change) in one of the BRCA genes, and are at high risk for developing ovarian cancer will return to clinic every six months to undergo screening for ovarian cancer symptoms, physical examination, CA125, HE4, and transvaginal ultrasound.
干预措施: Ovarian Cancer Screening (Other)
Ovarian Cancer Screening
Woman who have a mutation (genetic change) in one of the BRCA genes, and are at high risk for developing ovarian cancer will return to clinic every six months to undergo screening for ovarian cancer symptoms, physical examination, CA125, HE4, and transvaginal ultrasound.
干预措施: Questionnaire (Behavioral)
Ovarian Cancer Screening
Woman who have a mutation (genetic change) in one of the BRCA genes, and are at high risk for developing ovarian cancer will return to clinic every six months to undergo screening for ovarian cancer symptoms, physical examination, CA125, HE4, and transvaginal ultrasound.
干预措施: Transvaginal Ultrasound (Procedure)
Ovarian Cancer Screening
Woman who have a mutation (genetic change) in one of the BRCA genes, and are at high risk for developing ovarian cancer will return to clinic every six months to undergo screening for ovarian cancer symptoms, physical examination, CA125, HE4, and transvaginal ultrasound.
干预措施: Phone Call (Behavioral)
Prophylactic Salpingectomy with Delayed Oophorectomy (PSDO)
Woman who have a mutation (genetic change) in one of the BRCA genes, and are at high risk for developing ovarian cancer have salpingectomy performed as an outpatient procedure. After the 3-year follow up period, oophorectomy performed as an outpatient procedure.
干预措施: Prophylactic Salpingectomy with Delayed Oophorectomy (Procedure)
Prophylactic Salpingectomy with Delayed Oophorectomy (PSDO)
Woman who have a mutation (genetic change) in one of the BRCA genes, and are at high risk for developing ovarian cancer have salpingectomy performed as an outpatient procedure. After the 3-year follow up period, oophorectomy performed as an outpatient procedure.
干预措施: Questionnaire (Behavioral)
Prophylactic Salpingectomy with Delayed Oophorectomy (PSDO)
Woman who have a mutation (genetic change) in one of the BRCA genes, and are at high risk for developing ovarian cancer have salpingectomy performed as an outpatient procedure. After the 3-year follow up period, oophorectomy performed as an outpatient procedure.
干预措施: Transvaginal Ultrasound (Procedure)
Prophylactic Salpingectomy with Delayed Oophorectomy (PSDO)
Woman who have a mutation (genetic change) in one of the BRCA genes, and are at high risk for developing ovarian cancer have salpingectomy performed as an outpatient procedure. After the 3-year follow up period, oophorectomy performed as an outpatient procedure.
干预措施: Phone Call (Behavioral)
Risk-Reducing Salpingo-Oophorectomy (RRSO)
Woman who have a mutation (genetic change) in one of the BRCA genes, and are at high risk for developing ovarian cancer have risk-reducing salpingo-oophorectomy (RRSO) performed as an outpatient procedure.
干预措施: Risk-Reducing Salpingo-Oophorectomy (Procedure)
Risk-Reducing Salpingo-Oophorectomy (RRSO)
Woman who have a mutation (genetic change) in one of the BRCA genes, and are at high risk for developing ovarian cancer have risk-reducing salpingo-oophorectomy (RRSO) performed as an outpatient procedure.
干预措施: Questionnaire (Behavioral)
Risk-Reducing Salpingo-Oophorectomy (RRSO)
Woman who have a mutation (genetic change) in one of the BRCA genes, and are at high risk for developing ovarian cancer have risk-reducing salpingo-oophorectomy (RRSO) performed as an outpatient procedure.
干预措施: Transvaginal Ultrasound (Procedure)
Risk-Reducing Salpingo-Oophorectomy (RRSO)
Woman who have a mutation (genetic change) in one of the BRCA genes, and are at high risk for developing ovarian cancer have risk-reducing salpingo-oophorectomy (RRSO) performed as an outpatient procedure.
干预措施: Phone Call (Behavioral)
结局指标
主要结局
Patient Compliance with Prophylactic Salpingectomy with Delayed Oophorectomy Strategy
时间窗: Up to 5 years
The proportion of women who comply with the prophylactic salpingectomy with delayed oophorectomy strategy estimated with an exact 95% binomial confidence interval. If all 20 patients return for their scheduled oophorectomy the 95% confidence interval for the proportion of women who are compliant will be 0.846 to 1.00.
次要结局
- Number of occult malignancies(Up to 5 years)
- Number of complications(Up to 5 years)
- Type of complications(Up to 5 years)
- Change in quality of life measure(Baseline to up to 3 years)