ChiCTR2200061519Not yet recruitingEarly Phase 1
呼气挥发性有机物分子在早期肺结节良恶性鉴别的应用研究
企业资助1 site in 1 countryStarted: June 26, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Not yet recruiting
- Sponsor
- Locations
- 1
- Primary Endpoint
- 呼气挥发性有机物分子
Study Overview
Brief Summary
采用基于微型气相色谱技术的代谢气体分子分析色谱仪，针对肺结节(定义为结节直径介于 5mm 至 30mm 之间)患者，通过检测呼气中痕量的 VOC 气体分子，找到可以鉴别结节良恶性的关键 VOC 生物标记物分子组，建立 AI 诊断筛查模型，并初步验证此 VOC AI 模型在鉴别肺结节良恶性方面的效能。
Study Design
- Study Type
- 诊断试验
- Primary Purpose
- 连续入组
Eligibility Criteria
- Ages
- 20 to 80 (—)
- Sex
- All
Inclusion Criteria
- •年龄 20-80 岁，男女不限；
- •患者经由低剂量螺旋 CT、胸部 CT 普通扫描或高分辨薄层 CT 检查发现肺部结节；
- •肺部结节最大直径介于 5～30mm 之间；
- •三种影像学类型的肺结节都可以入组，即实性结节（SN）、非实性结节（NSN/GGO）和部分实性结节（PSN）；
- •该患者需要进行肺结节切除术以明确结节性质；
- •患者必须能够充分理解知情同意书，并能够亲自签署知情同意书。
Exclusion Criteria
- •患者在手术切除或活检后无法明确肺结节的病理诊断；
- •患者既往诊断有恶性肿瘤（已治愈的非恶性和色素瘤的皮肤癌和原位癌除外）。
Outcomes
Primary Outcomes
呼气挥发性有机物分子
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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