WISP (Women Choosing Surgical Prevention)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 374
- 试验地点
- 17
- 主要终点
- Percent of women with clinically meaningful change in the Female Sexual Function Index (FSFI) score
研究概览
简要总结
This phase II trial studies how well surgery works in preventing ovarian cancer in patients with genetic mutations at risk of ovarian cancer. Risk reducing salpingo oophorectomy (RRSO) is surgery to remove the fallopian tubes and ovaries at the same time. Interval salpingectomy with delayed oophorectomy (ISDO) is surgery to remove the fallopian tubes. It is not known whether ISDO works better than RRSO at lowering risk of ovarian cancer and improving the sexual function and psychosocial well-being in patients with genetic mutation.
详细描述
Primary Objectives:
1. To examine changes in female sexual function with the strategy of interval salpingectomy and delayed oophorectomy (ISDO) compared to the strategy of risk-reducing salpingo-oophorectomy (RRSO) for patients who carry genetic mutations that predispose them to ovarian cancer.
Secondary Objectives:
- To estimate the onset and severity of menopausal symptoms with ISDO compared to RRSO.
- To estimate quality of life with ISDO compared to RRSO.
- To examine participants' satisfaction level and cancer worry level with their choice of prophylactic procedures.
- To estimate the impact of ISDO compared to RRSO on mental health, including depression, anxiety, and sleep quality.
- To determine the compliance with delayed oophorectomy within the ISDO arm.
- To estimate the number of fallopian tube, ovarian, primary peritoneal malignancies and other malignancies over the course of the study.
- To identify common themes regarding influential factors in the decision to undergo risk reducing surgery in premenopausal women at genetic high-risk for ovarian can
OUTLINE: Patients are assigned to 1 of 2 arms.
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women must be ≥ 30 and ≤ 50 years of age.
- •Premenopausal women with a documented deleterious mutation in one of the following ovarian cancer genes: BRCA1, BRCA2, BRIP1, PALB2, RAD51C, RAD51D, BARD1, MSH2, MSH6, MLH1, PMS2, or EPCAM. Menopause is defined as ≥ 12 months of amenorrhea. However, for those patients with ≥ 12 months of amenorrhea who may be pre-menopausal, levels of FSH, LH, and estradiol in the pre-menopausal range will be acceptable.
- •Willing to undergo two surgical procedures (if chooses the ISDO arm).
- •Presence of at least 1 fallopian tube and 1 ovary. Prior unilateral salpingectomy is allowed; prior bilateral salpingectomy is not allowed
- •Patients who have undergone a prior tubal ligation will be eligible.
- •Participants may have a personal history of non-ovarian malignancy, but must:
- •Be without evidence of disease at enrollment
- •Remain premenopausal
- •Have completed treatment (including surgery, chemotherapy, radiotherapy or hormonal therapy) > 3 months prior to enrollment (other than non-melanoma skin cancer)
- •Willingness to return to the enrolling site for the study surgical procedures, including pre-operative and post-operative care.
- •Patients in the ISDO arm must be willing to return to the enrolling site for yearly ovarian cancer assessment.
- •Patients must understand that they will be permanently sterilized
排除标准
- •Women with a personal history of ovarian, fallopian tube, or primary peritoneal cancer.
- •Current treatment with Tamoxifen or Aromatase Inhibitors.
- •Medical comorbidities making surgery unsafe as determined by the patient's surgeon.
- •Women who are pregnant or post-partum (within 3 months of delivery).
- •Patients are deemed not pregnant by virtue of urine pregnancy test (UPT), transvaginal ultrasound, beta HCG, or best judgment of the investigator. Pregnancy testing is not required per protocol to determine study eligibility.
- •Women who become pregnant on the ISDO arm via reproductive technology can remain on study. However, data collection will be suspended during pregnancy and 3 months post-partum.
- •Women with elevated levels of CA125 (>50) or transvaginal ultrasound suggesting cancer, unless findings are consistent with endometriosis. CA125 and transvaginal ultrasounds must be the most recent, but no older than 1 year from the date of enrollment.
- •Inability to provide informed consent.
- •Inability to read or speak English.
研究组 & 干预措施
Arm I (ISDO)
Patients undergo ISDO.
干预措施: Laboratory Biomarker Analysis (Other)
Arm I (ISDO)
Patients undergo ISDO.
干预措施: Quality-of-Life Assessment (Other)
Arm I (ISDO)
Patients undergo ISDO.
干预措施: Salpingectomy (Procedure)
Arm II (RRSO)
Patients undergo RRSO.
干预措施: Laboratory Biomarker Analysis (Other)
Arm II (RRSO)
Patients undergo RRSO.
干预措施: Quality-of-Life Assessment (Other)
Arm II (RRSO)
Patients undergo RRSO.
干预措施: Salpingo-Oophorectomy (Procedure)
Arm I (ISDO)
Patients undergo ISDO.
干预措施: Oophorectomy (Procedure)
结局指标
主要结局
Percent of women with clinically meaningful change in the Female Sexual Function Index (FSFI) score
时间窗: From baseline to 6 months
Will be calculated using the Cochran-Mantel-Haenszel test stratified by age, with 5-year age groups. We will use propensity score methods to account for potential differences between interval salpingectomy with delayed oophorectomy (ISDO) and risk-reducing bilateral salpingectomy with oophorectomy (RRSO) arms with respect to age, baseline survey scores, and other potential confounders, and we will use the propensity scores as inverse weights in logistic regression to model the logit of the probability of having a clinically meaningful change in FSFI score from baseline to 6 months as our primary analysis.
次要结局
未报告次要终点