NCT01680575Unknown不适用
Development of a Risk Model Predicting Chemotherapy-induced Grade 3-4 Neutropenia by Paclitaxel/Carboplatin in Epithelial Ovarian Cancer: Prospective Observational Study for Model Development and Retrospective Study for Validation of Developed Model
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 750
- 试验地点
- 1
- 主要终点
- Risk prediction model for grade 3-4 chemotherapy induced neutropenia
研究概览
简要总结
To develop a robust prediction model to predict the occurrence of grade 3-4 neutropenia induced by adjuvant paclitaxel/carboplatin chemotherapy in patients with epithelial ovarian cancer and to validate this model.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with FIGO stage I-IV epithelial ovarian cancer after staging or debulking surgery
- •Patients who is planned to receive (prospective cohort) ro who received (retrospective cohort) adjuvant chemotherapy with paclitaxel and carboplatin
- •Patients who have signed approved informed consent
排除标准
- •Uncontrolled medical disease
- •Active infectious disease
- •Previous pelvic radiation therapy
- •Previous chemotherapy (prospective cohort)
- •Patients with disease which can cause neutropenia
- •Patients who will receive other targeted therapy or immunotherapy during adjuvant therapy (prospective cohort).
- •Pregnant or lactating woman
结局指标
主要结局
Risk prediction model for grade 3-4 chemotherapy induced neutropenia
时间窗: 1 year
次要结局
- The association between mannose-binding lectin 2 gene SNP and neutropenia(1 year)
研究者
Jeong-Yeol Park
Clinical Assistant Professor
Asan Medical Center
研究点 (1)
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