Non-interventional, Multicenter, Prospective Register Study to Describe the Treatment Pattern of Platinum-sensitive Relapsed Epithelial Ovarian Cancer (ROC) Patients in Austria
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 9
- 主要终点
- To assess treatment patterns and the reasons for selecting these treatments in patients with platinum-sensitive ROC after first relapse in Austria
研究概览
简要总结
Various treatment options exist for patients with platinum-sensitive relapsed epithelial ovarian cancer (ROC).
The register will provide an overview of chosen treatments including the reasons, why these options were chosen.
详细描述
Patients at their first platinum-sensitive ROC will be invited to participate in the register.
These are all patients with recurrent disease 6 or more months after the last cycle of platinum containing chemotherapy.
The Observation Period will begin by signing the Informed Consent Form (ICF) and will continue for up to a total of 24 months (+/- 4 weeks) after the diagnosis of the first relapse or until patient discontinuation for any reason, or patient's death.
Data on First Study Visit, Subsequent Recurrence during Observation Period and Last Observation will be collected in the electronic Case Report Form (eCRF).
The register will identify symptoms and factors that led to the diagnosis, chosen therapy and the reason for choosing the therapy. At inclusion, data on general patient information, primary diagnosis, previous therapy, and tumor characteristics are collected. During the course of observation data on systemic and maintenance treatments, radiotherapies, surgeries, and outcome are documented.
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 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18 years or older
- •Presence of first platinum-sensitive ROC (ovarian, peritoneal and/or fallopian tube cancer)
- •Must have received at least 4 cycles of chemotherapy during primary therapy
- •At time of inclusion a treatment for ROC must be planned
- •Patients must not have more than 1 prior line of chemotherapy
- •Signed informed consent
排除标准
- •No knowledge of spoken and written German
- •Signed informed consent is not given
结局指标
主要结局
To assess treatment patterns and the reasons for selecting these treatments in patients with platinum-sensitive ROC after first relapse in Austria
时间窗: Two years
Descriptive Data Analysis
次要结局
- Overall Survival(2 years per patient)
- Progression Free Survival(2 years per patient)
- Assess Treatments(2 years per patient)
- Overall Survival Description(2 years per patient)