International Registration of Isolated STIC: to Report and Investigate the Risk of Serous Peritoneal Carcinomatosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 600
- 主要终点
- The risk for peritoneal carcinomatosis in women with isolated STIC
研究概览
简要总结
To prospectively assess the incidence of peritoneal carcinomatosis for women with isolated STIC (serous tubal intraepithelial carcinoma). Moreover, to identify histopathological characteristics of STIC which are reproducible and associated to the risk of peritoneal carcinomatosis and to report the findings of additional diagnostics.
详细描述
Women with a BRCA pathogenic variant (PV) undergo a risk-reducing salpingo-oophorectomy (RRSO) to reduce their ovarian cancer risk of 17-44%. A residual risk for peritoneal cancer (PC) persists, with most patients having extensive tumour spread throughout the abdomen. Despite surgery and chemotherapy, the five-year survival rate of PC is only 14-30%. Recently it became apparent that PC is frequently preceded by a preinvasive serous tubal intraepithelial cancer (STIC) at RRSO. The entity STIC is often found conjointly with ovarian cancer, but can also be present as an isolated condition, mostly in high risk women. If this STIC is found at RRSO, the risk for PC was found to be 27.5% (95% CI, 15.6-43.9) after ten years whilst this risk was <1% without STIC. The pathophysiological mechanism of this association is not yet known and it is unknown which women with STIC are most at risk. Moreover, the additional value of diagnostics and management is unknown as data is lacking.
Objective
To prospectively assess the PC incidence for women with isolated STIC, to identify histopathological characteristics of STIC which are reproducible and associated to the risk of PC, and to report the findings of additional diagnostics.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Bilateral salpingectomy (with or without oophorectomy)
- •A serous tubal intraepithelial carcinoma at histopathological review
排除标准
- •Invasive cancer at initial surgery or pathological examination (either macroscopic and/or microscopic)
结局指标
主要结局
The risk for peritoneal carcinomatosis in women with isolated STIC
时间窗: 10 years
次要结局
- Additional diagnostics(3 months)
- Histopathological characteristics(5-10 years)
- Risk factors(5-10 years)