A Prospective Cohort Study of Chinese Patients With Pulmonary Nodules: Prediction of Lung Cancer Using Noninvasive Biomarkers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,000
- 试验地点
- 6
- 主要终点
- The changes in genomic landscape related to progression from Stage 0 to Stage I lung cancer that could be utilized for early lung cancer diagnosis and intervention.
研究概览
简要总结
The broad goals of this study is to identify changes in genomic landscape during transition from stage 0 to stage 1 lung cancer.
This study intends to determine whether diagnostic biomarkers measured in minimally invasive biospecimens are able to correlate molecular, clinical and imaging features to distinguish malignant from benign pulmonary nodules. The diagnostic markers once validated can be used as broad screening tools for lung cancer.
详细描述
The four-year study aims to recruit 3000 patients (1500 GGO and 1500 solid / semi solid nodules) in the study based on qualifying for a lung cancer screening CT or by routine CT chest with the observation of a lung nodule between 5-30mm diameter. These patients will be followed for 2~3 years and be managed according to institutional standard of care. This may involve the Chinese Thoracic Society guideline or Fleischner criteria (either 2013 or 2017 guidelines). The clinical data, CT imaging and biospecimens will be collected during each visit. Once a patient undergoes surgery, tissue samples (FFPE) from surgery will also be collected.
The gold standard for lung cancer diagnosis will be the results of bronchoscopic biopsy of lung or lymph nodes, percutaneous biopsy of lung or other organ sites, surgical biopsy or resection, or a minimum follow-up of 2 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 Years and older, both male and female
- •Willing and able to provide a written informed consent
- •Radiologic diagnosis of solid indeterminate pulmonary nodule (5-30 mm) OR semi-solid (mixed density) nodule with solid component of at least 5mm OR non-solid nodule (including pGGO); must be of appropriate size at enrollment, but nodule(s) may have been first identified within 12 months prior. Furthermore, nodule(s) < 5 mm in size may have been first identified greater than 12 months prior to enrollment though it must grow into the appropriate size range (5-30 mm) within 12 months prior to enrollment. If multiple nodules were diagnosed, choose the most representative one with the longest diameter as the target lesion; if two or more nodules are of the same largest size, choose the one with the perpendicular longest diameter
- •CT scan completed within 3 months prior to enrollment
- •Agree to tolerate all biospecimen collection as required by protocol
- •Agree to comply with standard of care follow up visits including clinical exams, diagnostic work-ups, and imaging for 2~3 years from enrollment
- •Agree to fill out Patient Lung History Questionnaire
排除标准
- •History or previous diagnosis of primary lung cancer, metastatic lung cancer, or any other non-lung cancer within 5 years (exceptions are adequately treated squamous and basal cell carcinomas of the skin, carcinoma in situ of the cervix or breast)
- •Any receipt of cytotoxic agents within the past 6 months
- •Any symptoms of lung cancer (unexplained weight loss, recent hemoptysis)
- •Pregnant or lactating women
- •Underwent invasive biopsy procedures (e.g. bronchoscopies or CT-guided transthoracic biopsies) before enrollment
- •Receipt of transfusion within 30 days prior to enrollment
- •Fail to understand or provide a written informed consent
结局指标
主要结局
The changes in genomic landscape related to progression from Stage 0 to Stage I lung cancer that could be utilized for early lung cancer diagnosis and intervention.
时间窗: 3 Years
The transcriptome of benign versus malignant by using RNA sequencing. The cfDNA in blood samples collected from patients with pulmonary nodules.
次要结局
- The biomarker changes in nasal epithelium and matching blood and tissue samples so as to validate molecular tests using nasal epithelium to predict lung cancer.(3 Years)
- The individual or combinations of clinical, molecular, and imaging features can reliably identify individuals with indeterminate lung nodules 5-30 mm who have lung cancer(3 Years)