Confocal Laser Endomicroscopy (CLE) Score for the Detection of Non-Small Cell Lung Cancer (NSCLC) and Rapid Surgical Decision-Making
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of the CLE-based score for non-small cell lung cancer (NSCLC) detection
研究概览
简要总结
The goal of this observational study is to evaluate whether confocal laser endomicroscopy (CLE) can improve the real-time diagnosis of non-small cell lung cancer (NSCLC) in patients undergoing bronchoscopic biopsy for suspected lung tumors. The main questions it aims to answer are:
- Can a high-specificity CLE-based score accurately identify NSCLC during endoscopic procedures?
- Can CLE imaging criteria improve biopsy yield and help differentiate histological subtypes (e.g., squamous cell carcinoma, adenocarcinoma, carcinoid tumors)?
Participants will:
- Undergo standard bronchoscopic navigation procedures with additional real-time imaging using CLE and biopsy
- Have CLE findings compared with standard histopathological analysis of biopsy samples
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
- All
- 接受健康志愿者
- 否
入选标准
- •Patient for whom endobronchial navigation-guided biopsy is indicated
- •Complete medical data (CLE images and histopathological results)
排除标准
- •Persons referred to in Articles L. 1121-5, L. 1121-7, and L. 1121-8 of the French Public Health Code:
- •Individuals under 18 years of age
- •Adult persons subject to legal protection measures (guardianship, curatorship, or judicial protection)
- •Adult persons unable to express their consent
- •Persons deprived of liberty by judicial or administrative decision, and persons receiving psychiatric care under Articles L. 3212-1 and L. 3213-1
研究组 & 干预措施
CLE based bronchoscopic navigation Group
干预措施: bronchoscopic navigation with CLE (Procedure)
结局指标
主要结局
Diagnostic accuracy of the CLE-based score for non-small cell lung cancer (NSCLC) detection
时间窗: During the endoscopic procedure and confirmed after biopsy analysis (up to 7 days)
Proportion of cases in which the CLE imaging score correctly identifies NSCLC, using standard histopathology from biopsy samples as the reference standard
次要结局
- Improvement of biopsy yield using CLE imaging criteria(During the endoscopic procedure and confirmed after pathology analysis (up to 7 days))
- Identification of NSCLC histological subtypes using CLE imaging(During the procedure and confirmed after biopsy analysis (up to 7 days))
研究者
SCHNEDECKER Lucie
Consultant Pathologist
Central Hospital, Nancy, France