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| Name | Class |
|---|---|
| Xinqiao Hospital of Chongqing | OTHER |
| Shanghai Pulmonary Hospital, Shanghai, China | OTHER |
| Shanghai Chest Hospital | OTHER |
| Wuhan University |
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This multicenter prospective observational and exploratory study aims to develop and validate a novel multi-omics-based computational method for neoantigen prediction in non-small cell lung cancer (NSCLC), and discover biomarkers for evaluation of PD-1/PD-L1 inhibitor's efficacy in patients of advanced NSCLC.
Tumor tissues and blood samples from about 400 patients with non-small-cell lung cancer (NSCLC) will be collected for the study, which will be subject to NGS-based genomic, transcriptomic, and methylomic profiling in order to construct a multi-omics landscape of NSCLC. These multi-omics data will be used to construct and validate a novel computational method for neoantigen prediction. Additionally, biomarkers will be explored for prognosis and patient stratification, as well as for evaluation of PD-1/PD-L1 inhibitor treatment efficacy in patients of advanced NSCLC.
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| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) | Progression free survival (PFS) is defined as the period a participant remains alive without disease progression after study registration. Tumor status is assessed per the Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) by computed tomography (CT), positron emission tomography (PET) CT and/or X rays. Complete Response (CR) = Disappearance of all lesions Partial Response (PR) = ≥30% decrease in the sum of the lesion diameters Overall Response (OR) = CR + PR Progressive disease (PD) = 20% increase in the sum of lesion diameters, and/or the appearance of 1+ new lesion(s) Stable disease (SD) = Small changes that do not meet any of the above criteria | 2 years |
| Disease-free survival (DFS) | Disease-free survival (DFS) is defined as the number of participants remaining alive without disease progression (PD), symptomatic deterioration or death due to any cause. DFS is assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria, as follows. Complete Response (CR) = Disappearance of all target lesions Partial Response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesions Progressive disease (PD) = 20% increase in the sum of the diameters of target lesions (must be > 5 mm), unequivocal progression of non-target lesions, and/or the appearance of one or more new lesion(s) Stable disease (SD) = Small changes that do not meet any of the above criteria. The outcome will be reported as the number of participants who meet the criteria for DFS, a number without dispersion. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | Overall survival (OS) defined as the duration from study registration until death due to any cause. The outcome will be reported as the number of participants known to be alive at 24 months after study registration, a number without dispersion. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with stage I-IV non-small cell lung cancer
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| Name | Affiliation | Role |
|---|---|---|
| Bo Zhu | Xinqiao Hospital of Chongqing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Affiliated Hospital of Army Medical University | Chongqing | Chongqing Municipality | 400000 | China |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| OTHER |
| Renmin Hospital of Wuhan University | OTHER |
| Tongji Hospital | OTHER |
| Southwest Hospital, China | OTHER |
| Daping Hospital and the Research Institute of Surgery of the Third Military Medical University | OTHER |
| People's Hospital of Chongqing | OTHER |
| Sichuan Cancer Hospital and Research Institute | OTHER |
| The Second Affiliated Hospital of Kunming Medical University | OTHER |
| First Affiliated Hospital of Wenzhou Medical University | OTHER |
| The Affiliated Hospital Of Southwest Medical University | OTHER |
| Guizhou Provincial People's Hospital | OTHER |
| The First Affiliated Hospital of Zhengzhou University | OTHER |
| Shanxi Province Cancer Hospital | OTHER |
| First Hospital of China Medical University | OTHER |
| Fujian Provincial Hospital | OTHER |
| Peking University Shenzhen Hospital | OTHER |
| Affiliated Cancer Hospital of Shantou University Medical College | OTHER |
| The Second Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine | OTHER |
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |