A Bidirectional Cohort Study on Prophylactic Resection Surgery in Populations at Moderate-to-High Risk for Hereditary Ovarian Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- Incidence of Ovarian Cancer
研究概览
简要总结
The goal of this multi-center observational study is to learn about the effectiveness and safety of different prophylactic (preventive) surgical options in women at moderate-to-high genetic risk for hereditary ovarian cancer (HOC).
The main questions it aims to answer are:
Does individualized prophylactic surgery (such as removing fallopian tubes now and delaying ovary removal) effectively reduce the risk of developing ovarian cancer compared to standard care or close monitoring?
How do these different surgical interventions affect a woman's ovarian function and quality of life?
What Participants Will Do:
Participants who are healthy carriers of specific genetic mutations (such as BRCA1/2, RAD51C/D, etc.) will be followed in a bidirectional cohort. Depending on the medical care and surgical path they choose with their doctors (Standard RRSO, Delayed Oophorectomy, or Close Monitoring), researchers will collect their clinical data, surgical pathology results, and follow-up information regarding cancer incidence and quality of life for 3 years.
详细描述
- Study Rationale and Background Epithelial ovarian cancer (OC) remains a significant health burden in China, with high mortality due to the lack of effective early screening methods. Approximately 20% of OC cases are attributed to hereditary factors, primarily germline pathogenic variants in BRCA1/2 and other homologous recombination repair (HRR) genes.
The traditional standard for risk reduction is Risk-Reducing Salpingo-Oophorectomy (RRSO). However, the "dualistic model" of ovarian carcinogenesis suggests that a significant proportion of high-grade serous carcinomas (HGSC) originate as Serous Tubal Intraepithelial Carcinoma (STIC) in the fallopian tubes. This provides a biological rationale for Prophylactic Salpingectomy with Delayed Oophorectomy (PSDO, also known as RS-DO). This study aims to establish a Chinese bidirectional cohort to evaluate the effectiveness, safety, and impact on quality of life (QoL) of individualized prophylactic surgical strategies. 2. Study Design and Cohort Construction This is a bidirectional (combined retrospective and prospective) cohort study.
Retrospective Component: Data will be extracted from clinical records dating back to 2020 for individuals who meet the high-risk genetic criteria and have previously undergone risk-reducing surgery or entered clinical monitoring.
Prospective Component: Eligible participants will be recruited and followed for a minimum of 5 years. Participants are categorized into three cohorts based on the clinical intervention received:
RRSO Group: Concomitant removal of fallopian tubes and ovaries.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Gender: Female. Age: 18 years or older at the time of enrollment.Genetic Risk: Documented carriers of pathogenic or likely pathogenic germline mutations in high-risk ovarian cancer susceptibility genes (including BRCA1, BRCA2, RAD51C, RAD51D, BRIP1, PALB2). Data Availability: Willing to provide informed consent and allow access to clinical records, genetic testing reports, and follow-up data (bidirectional cohort). Psychosocial Status: Ability to complete quality of life and psychological assessment scales (e.g., GCS, SF-36, FSFI).
排除标准
- •Prior Malignancy: History of ovarian, fallopian tube, or primary peritoneal cancer prior to the baseline intervention. Synchronous Malignancy: Diagnosis of any other advanced-stage malignancy. Inability to Follow-up: Significant psychological, social, or geographical factors that would prevent regular long-term follow-up (3 years). Previous Extensive Pelvic Surgery: History of extensive pelvic surgery that precludes the feasibility of laparoscopic prophylactic salpingectomy or oophorectomy.
研究组 & 干预措施
Label 1: Standard RRSO Group. Label 2: Individualized RS-DO Group. Label 3: Close Monitoring Group
Description of Label 1: Participants undergoing concurrent bilateral salpingo-oophorectomy per guidelines. Description of Label 2: Participants undergoing salpingectomy with delayed oophorectomy to preserve hormones.Description of Label 3: Participants declining surgery and choosing regular ultrasound and CA-125 surveillance.
结局指标
主要结局
Incidence of Ovarian Cancer
时间窗: From the date of enrollment/surgery up to 15 years.
The primary efficacy endpoint is the development of histologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer among high-risk mutation carriers in different intervention groups.
次要结局
- Incidence of Breast Cancer(From the date of enrollment up to 15 years.)
- Incidence of Serous Tubal Intraepithelial Carcinoma (STIC)(At the time of prophylactic surgery (approx. 1 day))
- Comprehensive Assessment of Quality of Life and Menopausal Symptoms(Baseline, 1 month, 6 months and 1 year post-enrollment.)
- Evaluation of Psychological Distress(Baseline, 1 month, 6 months and 1 year post-enrollment.)