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.
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.
Study Type
OBSERVATIONAL
Enrollment
3,000
A genomic and transcriptomic landscape analysis will be developed to identify and characterize the transcriptome of benign versus malignant by using RNA sequencing, and to profile cfDNA in blood samples collected from patients with pulmonary nodules.
Department of Respiratory and Critical Care Medicine, Beijing Chaoyang Hospital
Beijing, China
NOT_YET_RECRUITINGDepartment of Respiratory Medicine, West China Hospital of Sichuan University
Chengdu, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
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.
The transcriptome of benign versus malignant by using RNA sequencing. The cfDNA in blood samples collected from patients with pulmonary nodules.
Time frame: 3 Years
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.
The biomarker change in nasal epithelium to predict lung cancer.
Time frame: 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
The individual or combination of clinical, molecular, and imaging features can reliably identify individuals who have lung cancer
Time frame: 3 Years
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Department of Respiratory, Qilu Hospital, Shandong University
Jinan, China
NOT_YET_RECRUITINGDepartment of Pulmonary Medicine, Zhongshan Hospital, Fudan University
Shanghai, China
NOT_YET_RECRUITINGDepartment of Respiratory and Critical Care Medicine, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
NOT_YET_RECRUITING