Integrative Prognostic Value of Inflammatory Markers and KELIM Score in Ovarian Cancer Patients Treated With Neoadjuvant Chemotherapy.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
This is a retrospective observational study to evaluate the integrative prognostic value of inflammatory markers, specifically the neutrophil-lymphocyte ratio (NLR) and platelet-lymphocyte ratio (PLR), alongside the CA-125 Elimination rate constant K (KELIM) score in advanced ovarian cancer patients. The study includes patients with advanced serous ovarian cancer (stage III or IV) who received neoadjuvant platinum-based chemotherapy followed by interval debulking surgery at Sohag University Hospital and Sohag Cancer Center between 2022 and 2025. The primary objective is to evaluate how well these biomarkers predict survival outcomes, including progression-free survival (PFS) and overall survival (OS). Additionally, the study aims to assess their significance in predicting the success of complete versus incomplete cytoreductive surgery following neoadjuvant chemotherapy.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged \ge 18 years old., Histologically confirmed advanced epithelial ovarian cancer (High-Grade Serous Ovarian Carcinoma), Stage III or IV.
- •Patients who received platinum-based neoadjuvant chemotherapy (NACT) followed by interval debulking surgery (IDS) at Sohag University Hospital or Sohag Cancer Center between 2022 and
- •Available complete medical records, including pre-treatment baseline CBC (for NLR and PLR calculation) and longitudinal CA-125 levels (for KELIM score estimation).
排除标准
- •Patients with non-epithelial ovarian tumors (e.g., germ cell tumors, sex cord-stromal tumors).
- •Patients who underwent primary debulking surgery (PDS) before receiving chemotherapy.
- •Patients with concurrent active malignancies or a history of other cancers within the past 5 years.
- •Patients with active systemic inflammatory diseases, hematological disorders, or severe infections at baseline that could interfere with baseline inflammatory markers (NLR/PLR).
- •Incomplete or missing clinical, surgical, or follow-up data.
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: From the date of diagnosis up to 4 years (assessed using retrospective medical records of patients treated between 2022 and 2025).
Evaluation of the prognostic value of baseline neutrophil lymphocyte ratio, platelet lymphocyte ratio, and CA 125 KELIM score in predicting progression-free survival in locally advanced ovarian cancer patients receiving platinum-based neoadjuvant chemotherapy followed by interval debulking surgery. PFS is calculated as the time from the date of diagnosis to the date of first documented clinical or radiological disease progression, or death from any cause.
Overall Survival (OS)
时间窗: From the date of diagnosis up to 4 years (assessed using retrospective medical records of patients treated between 2022 and 2025).
Evaluation of the prognostic value of baseline neutrophil lymphocyte ratio, platelet lymphocyte ratio, and CA 125 KELIM score in predicting overall survival in locally advanced ovarian cancer patients receiving platinum-based neoadjuvant chemotherapy followed by interval debulking surgery. OS is calculated as the time from the date of diagnosis to the date of death from any cause.
次要结局
- Completeness of Interval Cytoreductive Surgery(At the time of interval debulking surgery (typically performed after 3 to 6 cycles of neoadjuvant chemotherapy).)
研究者
Aya Ahmed Nasser
Proffesor of oncology and nuclear medicine Dr Sayed Mostafa Ali
Sohag University