Risk-Reducing Surgeries of Salpingo-oophorectomy With/Without Hysterectomy for Carriers With Mutation Genes of Hereditary Ovarian Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Occult cancer or precancerous lesion in histological specimen
研究概览
简要总结
Based on studies of "Inherited Susceptible Genes Among Epithelial Ovarian Cancer" (NCT03015376, clinicaltrials.gov) and "Cohort Study of Universal Screening for Lynch Syndrome in Chinese Patients of Endometrial Cancer" (NCT03291106, clinicaltrials.gov), we provide risk-reducing surgeries of salpingo-oophorectomy with/without hysterectomy for healthy carriers with mutation genes of hereditary ovarian cancer, which is defined ovarian cancer with relevant pathogenic mutations.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Carriers with known and definite mutation genes of hereditary ovarian cancer.
- •With children and without further requirement of pregnancy.
- •No less than 35 years for carriers with mutation gene of BRCA
- •No less than 40 years for carriers with mutation gene of BRCA
- •No less than 45 years for carriers with mutation genes of BRIP1, RAD51C, RAD51D and RAD
- •No less than 50 years for carriers with mutation genes of ATM, MSH2, MLH1, SH6, PMS2, EPCAM and STK11.
排除标准
- •Without children.
- •Not reaching appreciate ages.
- •With contraindications of laparoscopy.
- •Refusal of risk-reducing surgeries.
研究组 & 干预措施
HBOCS
For carriers with mutation genes of BRCA1, BRCA2 (both belonging to mutation genes of hereditary breast and ovarian cancer syndrome, HBOCS) and ATM, BRIP1, RAD51, RAD51C, and RAD51D (all belonging to mutation genes of other hereditary ovarian cancer syndrome), if they demand for risk-reducing surgeries, counseling, decision-making analysis, then salpingo-oophorectomy only by laparoscopy and long-term follow-up are provided.
干预措施: salpingo-oophorectomy only by laparoscopy (Procedure)
Lynch syndromes
for carriers with mutation genes of MLH1, MSH2, MSH6, PMS2, EPCAM (all belonging to mutation genes of Lynch syndromes) and STK11, , if they demand for risk-reducing surgeries, counseling, decision-making analysis, then salpingo-oophorectomy with hysterectomy by laparoscopy and long-term follow-up are provided.
干预措施: salpingo-oophorectomy with hysterectomy by laparoscopy (Procedure)
Refusal to surgery
For carriers with any mutation genes (BRCA1, BRCA2, ATM, BRIP1, RAD51, RAD51C, RAD51D, STK11, MLH1, MSH2, MSH6, PMS2 and EPCAM) but refusal to any risk-reducing surgeries, counseling, decision-making analysis, and then long-term follow-up are provided.
干预措施: Follow-up (Other)
结局指标
主要结局
Occult cancer or precancerous lesion in histological specimen
时间窗: 5 years
Precancerous lesions include serous tubal intraepithelial carcinoma (STIC) and endometrial intraepithelial neoplasia (EIN)
次要结局
- Overall survival(10 years)
- Incidence of primary uterine cancer(10 years)
- Incidence of primary peritoneal carcinoma(10 years)
研究者
Lei Li
Professor
Peking Union Medical College Hospital