Treatment-Associated Longitudinal Plasma Proteomic Remodeling in Ovarian Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Treatment-associated changes in circulating plasma protein levels
研究概览
简要总结
This longitudinal observational study investigates treatment-associated changes in the circulating plasma proteome of patients with ovarian cancer undergoing standard treatment. Although CA125 and HE4 are established biomarkers for monitoring treatment response, they provide only a limited view of the complex biological processes occurring during therapy.
The study includes patients with epithelial ovarian cancer and primary peritoneal Müllerian tumors who underwent surgery and/or platinum-based chemotherapy. Plasma samples were collected at three predefined treatment timepoints: before surgery (T1), after surgery (T2), and after completion of chemotherapy (T3). A panel of 92 circulating proteins was quantified using Olink proximity extension assay technology. Longitudinal proteomic changes were evaluated in relation to established clinical biomarkers (CA125 and HE4), exploratory proliferation-associated biomarker thymidine kinase 1 (TK1), and KELIM-defined chemosensitivity.
The primary objective is to characterize treatment-associated remodeling of the circulating proteome and determine whether these molecular changes reflect tumor burden reduction, treatment exposure, or chemotherapy sensitivity. Secondary objectives include identification of proteins and biological pathways associated with treatment timepoints and assessment of concordance between proteomic changes and established clinical biomarkers.
This study aims to improve understanding of dynamic tumor-host interactions during ovarian cancer treatment and to explore the potential role of longitudinal proteomic profiling as a complement to conventional biomarker monitoring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Age ≥18 years.
- •Histologically confirmed epithelial ovarian cancer or primary peritoneal Müllerian carcinoma.
- •Undergoing standard treatment including surgery and/or systemic therapy.
- •Availability of plasma samples collected at one or more predefined treatment timepoints (pre-operative, post-operative, and/or post-chemotherapy).
- •Availability of corresponding clinical and biomarker data (CA125 and/or HE4).
- •Written informed consent
排除标准
- •Non-epithelial ovarian malignancies.
- •Insufficient plasma sample volume or inadequate sample quality for proteomic analysis.
- •Missing essential clinical data required for study analyses.
- •Withdrawal of informed consent.
- •Concurrent participation in another study that would prevent interpretation of biomarker analyses.
结局指标
主要结局
Treatment-associated changes in circulating plasma protein levels
时间窗: Time 1 (Baseline, prior to primary cytoreductive surgery); Time 2 (1 month after primary cytoreductive surgery); Time 3 (after completion of first-line chemotherapy, up to 12 months after treatment initiation).
Identification of circulating proteins significantly associated with treatment timepoint (pre-operative, post-operative, and post-chemotherapy) as measured by Olink normalized protein expression (NPX) values and analyzed using longitudinal mixed-effects models.
次要结局
- Changes in serum CA125 and HE4 concentrations across treatment timepoints and their association with longitudinal proteomic remodeling.(Time 1 (Baseline, prior to surgery); Time 2 (1 month after primary cytoreductive surgery); Time 3 (after completion of first-line chemotherapy, up to 12 months after treatment initiation).)