A Prospective Cohort Study of Chinese Patients With Pulmonary Nodules: Prediction of Lung Cancer Using Noninvasive Biomarkers
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|ClinicalTrials.gov Identifier: NCT04462185|
Recruitment Status : Recruiting
First Posted : July 8, 2020
Last Update Posted : July 8, 2020
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.
|Condition or disease||Intervention/treatment|
|Pulmonary Nodules||Diagnostic Test: A genomic and transcriptomic landscape analysis|
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|
|Estimated Enrollment :||3000 participants|
|Official Title:||A Prospective Cohort Study of Chinese Patients With Pulmonary Nodules: Prediction of Lung Cancer Using Noninvasive Biomarkers|
|Actual Study Start Date :||July 1, 2020|
|Estimated Primary Completion Date :||June 2024|
|Estimated Study Completion Date :||December 2024|
This is a prospectively enrolling cohort study and 3000 patients (1500 GGO and 1500 solid / semi solid nodules) with radiologic diagnosis of indeterminate pulmonary nodule (5-30 mm) will be recruited. All participants will be followed up with chest CT or low-dose computed tomography (LDCT) scans for 2-3 years, and take the diagnostic test, a genomic and transcriptomic landscape analysis, at each visit.
Diagnostic Test: A genomic and transcriptomic landscape analysis
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.
- To identify 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. [ Time Frame: 3 Years ]
To identify and characterize the transcriptome of benign versus malignant by using RNA sequencing.
To profile cfDNA in blood samples collected from patients with pulmonary nodules.
- To compare and correlate biomarker changes in nasal epithelium and matching blood and tissue samples so as to validate molecular tests using nasal epithelium to predict lung cancer. [ Time Frame: 3 Years ]
- To determine if individual or combinations of clinical, molecular, and imaging features can reliably identify individuals with indeterminate lung nodules 5-30 mm who have lung cancer [ Time Frame: 3 Years ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04462185
|Contact: Bo WANGfirstname.lastname@example.org|
|Contact: Wenhua LIANG, MDemail@example.com|
|Department of Respiratory and Critical Care Medicine, Beijing Chaoyang Hospital||Not yet recruiting|
|Principal Investigator: Zhaohui TONG, MD|
|Department of Respiratory Medicine, West China Hospital of Sichuan University||Not yet recruiting|
|Principal Investigator: Dan LIU, MD|
|The First Affiliated Hospital of Guangzhou Medical University||Recruiting|
|Contact: Wenhua LIANG, MD firstname.lastname@example.org|
|Principal Investigator: Nanshan ZHONG, MD|
|Sub-Investigator: Wenhua LIANG, MD|
|Department of Respiratory, Qilu Hospital, Shandong University||Not yet recruiting|
|Principal Investigator: Wei XIAO, MD|
|Department of Pulmonary Medicine, Zhongshan Hospital, Fudan University||Not yet recruiting|
|Principal Investigator: Xin ZHANG, MD|
|Department of Respiratory and Critical Care Medicine, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology||Not yet recruiting|
|Principal Investigator: Jianping ZHAO, MD|
|Study Chair:||Nanshan ZHONG, MD||The First Affiliated Hospital of Guangzhou Medical University|