NCT01422265已完成不适用
Patient Reported Symptoms in Ovarian Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 主要终点
- Change in MD Anderson Symptom Inventory-Ovarian Cancer (MDASI-OC) sub-set symptom severity score before and after disease progression
研究概览
简要总结
This multicenter, observational, prospective study will include approximately 20 US-based centers, and approximately 142 patients diagnosed with epithelial ovarian cancer, primary peritoneal carcinoma or fallopian tube carcinoma, whose disease has recurred > 6 months after first-line platinum-based chemotherapy (first recurrence). Patients who have completed second-line chemotherapy and are currently in observation or undergoing bevacizumab maintenance treatment will be eligible to participate in the study.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically documented ovarian cancer, primary peritoneal carcinoma or fallopian tube carcinoma that has recurred > 6 months after platinum-based chemotherapy
- •This must be the first recurrence of the epithelial ovarian cancer, primary peritoneal carcinoma or fallopian tube carcinoma
- •Are at least two weeks but no more than 3 months after the completion of second-line cytotoxic chemotherapy
- •Are currently under observation or being treated with bevacizumab as a second-line maintenance therapy
- •Have a valid email address and access to the internet
- •Provide voluntary written informed consent
- •Speak and read English fluently
排除标准
- •Current participation in a blinded clinical trial for ovarian cancer treatment. (Participation in a trial involving only supportive care medicines and/or growth factors is acceptable)
- •Another primary diagnosis of cancer in a different site
结局指标
主要结局
Change in MD Anderson Symptom Inventory-Ovarian Cancer (MDASI-OC) sub-set symptom severity score before and after disease progression
时间窗: Up to 9 months
次要结局
- MDASI-OC Symptom Severity Score(Up to 9 months)
- MDASI-OC Symptom Interference Score(By month 9)
- HRQoL scores(Up to 9 months)
研究者
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