Design and Validation of Plasma Proteins and Cytokine Panels to Identify Markers Associated With Response to Niraparib as Maintenance Treatment After First-line Platinum-based Regimen in Patients With Advanced Ovarian Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 主要终点
- Multiplex protein detection panel - Early progression
研究概览
简要总结
PARPi inhibitors have been incorporated into managing first-line advanced ovarian cancer with different approvals depending on homologous recombination (HR) status. Niraparib has received approval independent from HR status. Although the benefit is more remarkable in HR-deficient patients, there is no biomarker to predict sustained response to niraparib at the start of treatment helping the clinician to make decisions among the different treatment options.
The aim of the LIBINI-1 (Liquid biopsy for predicting niraparib benefit if 1st line) study is to identify predictive biomarkers of sustained response to niraparib using liquid biopsy with two different technologies:
- Proteomic and secretome analysis tools. The first part of the LIBINI-1 project is to create a platform for rapid screening and analysis by multiple detections of niraparib response-associated proteins in patients with advanced ovarian cancer.
- ctDNA analysis. The second part of the LIBINI-1 project is to correlate the baseline level of ctDNA and change in ctDNA at 4 and 12 weeks with the benefit to niraparib.
详细描述
The main objective of this study (LIBINI-1 first part) is characterizing liquid biopsy profiles of ovarian cancer patients with sustained niraparib benefit as maintenance in the first line through proteomic and secretome analysis. The first part of LIBINI-1 is addressed by four individual subsequent objectives (see ANNEX 2).
Therefore, the primary objective is the development of a panel for multiplex detection of proteins associated with sustained benefit from niraparib maintenance.
For the execution of the primary objective the following consecutive secondary objectives are planned:
- Global characterization of proteins (proteome) in plasma samples from patients with and without benefit from niraparib maintenance. Identification of molecular pathways of proteins differentially expressed between both groups.
- Analysis of secreted proteins (secretome) in plasma samples of patients with and without benefit from niraparib maintenance.
3 & 4: Development of customized panels for multiplex detection of proteins associated with sustained benefit from niraparib maintenance.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Zejula (Niraparib)
Profiles of ovarian cancer patients with sustained niraparib benefit as maintenance in the first line
干预措施: Zejula (Niraparib) (Drug)
结局指标
主要结局
Multiplex protein detection panel - Early progression
时间窗: 0-24 months
To identify a multiplex protein detection panel based on protein and cytokine from plasma at baseline and at 4 and 12 weeks from baseline, associated with early progression, defined as progression in the first 6 months after initiation of niraparib maintenance.
Multiplex protein detection panel - Absence of progression
时间窗: 0-24 months
To identify a multiplex protein detection panel based on protein and cytokine from plasma at baseline and at 4 and 12 weeks from baseline, associated with absence of progression at 18 months after initiation of niraparib maintenance
次要结局
- Multiplex protein detection panel - Progression(0-12 months)
- Multiplex protein detection panel - Absence of progression (12 + 24 months)(0-24 months)
- Plasma protein identification - Absence of progression(0-24 months)
- Plasma cytokines identification - Progression(0-12 months)
- Plasma cytokines identification - Absence of progression(0-24 months)
- Plasma protein identification - Progression(0-12 months)