A Retrospective, Open-label, Biomarker Study for Early-stage Ovarian Clear Cell Carcinoma (OCCC) Patients at Risk of Recurrence
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 272
- 主要终点
- Presence of recurrence
研究概览
简要总结
The goal of this observational study is to determine the risk of recurrence in early-stage OCCC (Ovarian Clear Cell Carcinoma) patients who received postoperative adjuvant treatment.
Participants were received platinum-based adjuvant therapy following debulking surgery will be included for the study.
详细描述
This is a retrospective, global multicenter, single-arm, study for early-stage OCCC (Ovarian Clear Cell Carcinoma) patients at risk of recurrence following the first-line treatment. This study is planned to enroll 272 patients eligible for participation from two study sites in Taiwan, one in Korea, and one in Japan. The study will use archival Formalin-Fixed Paraffin-Embedded (FFPE) samples from patients who have received adjuvant therapy following debulking surgery. The study is designed to identify OCCC patients at risk for relapse and apply clinical stratification by IHC staining of 3 selected markers (CD45, CD8, tryptase) to prepare as clinical assays.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged ≥20 years old.
- •Participant with histologically confirmed OCCC of stage IC2, IC3, IIA and IIB by International Federation of Gynecology and Obstetrics (FIGO) 2014 system.
- •Participant has received platinum-based regimens for 3 to 6 cycles combined with paclitaxel, gemcitabine, cyclophosphamide, or bevacizumab adjuvant therapy following debulking surgery.
- •Formalin-fixed paraffin-embedded (FFPE) tissue samples available.
排除标准
- •Absence of histological confirmation of the diagnosis.
- •Unusable sample or biologically deteriorated.
结局指标
主要结局
Presence of recurrence
时间窗: up to 24 months
The clinical recurrence will be defined as disease progression. Analysis of the eligible histologically confirmed OCCC archival samples from Taiwan, Japan, and Korea that underwent immune-related gene expression will be provided.
次要结局
- 2-year PFS(up to 24 months)
- 5-year OS(up to 60 months)
- Outcomes for adjuvant treatment with paclitaxel-based chemotherapy(up to 60 months)