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临床试验/NCT06483919
NCT06483919进行中(未招募)不适用

The Predictive Value of Proteome Profiling for Brain Metastasis in Limited-Stage Small-Cell Lung Cancer

Jinming Yu1 个研究点 分布在 1 个国家目标入组 228 人开始时间: 2023年10月1日最近更新:
适应症

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

发起方
Jinming Yu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jinming Yu

Director of the hospital

Shandong Cancer Hospital and Institute

研究点 (1)

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