NCT05794698招募中不适用
Concordance Between Intraoperative Frozen Section and Postoperative Pathology in Diagnosing the Subtype of Lung Adenocarcinoma and Guiding the Surgical Procedure of Lung Adenocarcinoma: a Multi-center Prospective Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,063
- 试验地点
- 1
- 主要终点
- Concordance rate
研究概览
简要总结
This study is one of Eastern Cooperative Thoracic Oncology Projects (ECTOP-1014). The goal of this clinical trial is to confirm the concordance rate between intra-operative frozen section pathological diagnosis and post-operative paraffin embedded pathological diagnosis, and use this result to guide surgical treatment for early stage (cT1N0M0) lung adenocarcinomas.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who sign the informed consent form and are willing to complete the study according to the study protocol;
- •No previous history of cancer or pulmonary surgery;
- •Solitary lesions or multiple lesions with only one not manifesting as pure ground-glass opacity (GGO) on CT scan;
- •Peripheral clinical T1N0M0 patients that are eligible for surgery;
- •Non-small cell lung cancer is pathologically diagnosed before or at surgery;
- •No radiation therapy or chemotherapy before surgery.
排除标准
- •Patients with clinical stages other than T1N0M0;
- •The lesion cannot be completely resected;
- •Previous history of cancer;
- •Patients having received radiation therapy or chemotherapy.
结局指标
主要结局
Concordance rate
时间窗: 2 years
Concordance rate between intraoperative frozen section and postoperative paraffin embedded pathology in making the diagnosis of lung adenocarcinoma subtypes according to the WHO classifications.
次要结局
- Concordance rate(2 years)
- Recurrence-free survival (RFS)(5 years)
- Overall survival (OS)(5 years)
研究者
研究点 (1)
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