The Predictive Value of Proteome Profiling for Brain Metastasis in Limited-Stage Small-Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 228
- 试验地点
- 1
- 主要终点
- Brain metastases free survival
研究概览
简要总结
This study aims to evaluate the predictive value of proteome profiling for brain metastasis in limited-stage small-cell lung cancer
详细描述
Small-cell lung cancer (SCLC) constitutes approximately 15% of all lung cancer cases and is characterized by a highly aggressive disease course and poor prognosis. The brain is the most common metastatic site of SCLC, and it is also an important cause of high mortality. More than 20% of SCLC patients have developed brain metastasis (BM) at the first diagnosis. Prophylactic cranial irradiation (PCI), as an essential part of the treatment of limited-stage small-cell lung cancer (LS-SCLC), inevitably leads to neurotoxicity. Therefore, there is an urgent need for a convenient and effective prediction model to realize the early prediction of SCLC brain metastasis. Patients at high risk of brain metastases were treated with individualized PCI.
In the current study, the investigators have analyzed the proteome profiling using Data-independent Acquisition mass spectrometry (DIA-MS) method in formalin-fixed paraffin-embedded (FFPE) tissues from patients with limited-stage small-cell lung cancer. The prognostic biomarkers were developed based on machine learning in the non-PCI group. Patients in the non-PCI group were classified into modeling cohort and external validation cohort . Furthermore, the prognostic value of the candidate biomarkers be evaluated in a prospective cohort . Based on the brain metastasis model, patients were divided into high- and low-risk groups. The benefit value of PCI was analyzed in high-risk and low-risk groups.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years old
- •Histological / pathologic proved limited-stage small-cell lung cancer
- •Achieved a complete response (CR) or partial response (PR) after first-line CRT
排除标准
- •Simultaneous participation in another clinical trial
- •Brain MRI was not performed during treatment and follow-up
- •The follow-up time was less than 2 years
- •Patients presenting with other known malignancies for which they are receiving treatment
结局指标
主要结局
Brain metastases free survival
时间窗: 2 years
The length of time after the ending of primary treatment that the patient survives without any brain metastases signs or symptoms
次要结局
- Overall survival(2 years)
研究者
Jinming Yu
Director of the hospital
Shandong Cancer Hospital and Institute
