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This study is a prospective, national, multi-center, non-interventional study. The main purpose is to explore the initial adjuvant treatment pattern after radical resection for early-stage NSCLC patients with EGFR Mutation-Positive in the real world. The secondary purpose was to observe the postoperative follow-up treatment pattern and its subgroups (based on different EGFR mutation status and different clinical stages).
About 2,000 eNSCLC patients who received radical resection from about 50 research centers across the country will be included in this study, and will be followed up to 2 years after enrollment according to the actual clinical situation. The analysis method of this study is mainly based on descriptive statistics. The information about the human genetic resources of the subjects to be collected includes: demography, physical examination, WHO fitness status, medical history, smoking history, disease characteristics, surgical information, initial and follow-up adjuvant treatment pattern, laboratory tests, survival status, and adverse events related to gefitinib/osimertinib, serious adverse events/non-severe ADR, measures taken for adverse events, outcome of adverse events.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgeries | Procedure | Surgeries |
| Measure | Description | Time Frame |
|---|---|---|
| The distribution of participants with initial adjuvant treatment pattern after radical resection surgery for early-stage NSCLC patients | Descriptive summary statistics ( total number of cases, number of missing cases, frequency, and percentage of each category) were used to describe the distribution of participants with initial adjuvant treatment patterns, including chemical, targeted, combined, or other therapy. Set subgroup analysis for different initial adjuvant treatment pattern, including different clinical stages (according to phase I/ Phase II/ stage III) and different EGFR mutation status (19del or 21 L858R); | 2 years |
| Time on initial adjuvant treatment | Calculate the time from the start date to the end of initial adjuvant treatment. The total number of cases, number of missing cases, mean, standard deviation, median, 25th and 75th percentiles, minimum and maximum were used for statistical description. | 2 years |
| The interval from the date of operation to the start date of initial adjuvant therapy with EGFR-TKI. | Calculate the interval of operation to the adjuvant therapy with EGFR-TKI, which is classified into single-drug therapy and combined therapy. The total number of cases, number of missing cases, mean, standard deviation, median, 25th and 75th percentiles, minimum and maximum were used for statistical description. | 2 years |
| Numbers of therapy cycles of initial adjuvant treatment | The patients with chemotherapy were mainly calculated, divided into chemotherapy and targeted combination chemotherapy. The total number of chemotherapy cycles, the number of missing cases, the mean, standard deviation, the median, the 25th and 75th percentiles, the minimum and the maximum were statistically described | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| The distribution of participants with follow-up treatment pattern after initial adjuvant treatment. | Descriptive summary statistics ( total number of cases, number of missing cases, frequency, and percentage of each category) were used to describe the distribution of participants with follow-up treatment patterns after advanced events evaluated by an investigator, including chemical, targeted, combined, or other therapy. Set subgroup analysis for different follow-up treatment pattern including different clinical stages (according to phase I/ Phase II/ stage III) and different EGFR mutation status (19del or 21 L858R); |
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Inclusion Criteria:
Exclusion Criteria:
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Continuously enroll all patients with early-stage (stage I-III), histopathologically confirmed, and EGFR mutation-positive NSCLC after R0 resection
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| Name | Affiliation | Role |
|---|---|---|
| jianxing He, President | The First Affiliated Hospital of Guangzhou Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100000 | China | ||
| Beijing Chest Hospital,Capital Medical university |
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| 2 years |
| Time on follow-up treatment | Calculate the time from the start date to the end of follow-up treatment. The results are shown in months, to one decimal place. The total number of cases, number of missing cases, mean, standard deviation, median, 25th and 75th percentiles, minimum and maximum were used for statistical description. | 2 years |
| The interval from the date of operation to the start date of the follow-up treatment with EGFR-TKI. | Calculate the interval of operation to the follow-up treatment with EGFR-TKI, which is classified into single-drug therapy and combined therapy. The results are shown in months, to one decimal place. The total number of cases, number of missing cases, mean, standard deviation, median, 25th and 75th percentiles, minimum and maximum were used for statistical description. | 2 years |
| Numbers of therapy cycles of follow-up treatment | The patients with chemotherapy of follow-up treatment were mainly calculated, divided into chemotherapy and targeted combination chemotherapy. The total number of chemotherapy cycles, the number of missing cases, the mean, standard deviation, the median, the 25th and 75th percentiles, the minimum and the maximum were statistically described | 2 years |
| Beijing |
| Beijing Municipality |
| 100000 |
| China |
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100000 | China |
| Peking University People'S Hospital | Beijing | Beijing Municipality | 100000 | China |
| Peking University Third Hospital | Beijing | Beijing Municipality | 100000 | China |
| Xuanwu Hospital Capital Medical University | Beijing | Beijing Municipality | 100000 | China |
| Chongqing Cancer Hospital | Chongqing | Chongqing Municipality | 400000 | China |
| Fujian Provincial Hospital | Fuzhou | Fujian | 350000 | China |
| Cancer Center of Guangzhou Medical university | Guangzhou | Guangdong | 510000 | China |
| Guangdong Provincial People's Hospital | Guangzhou | Guangdong | 510000 | China |
| The First Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | 510000 | China |
| The First Affiliated Hospital,Sun Yat-sen University | Guangzhou | Guangdong | 510000 | China |
| Shenzhen People's Hospital | Shenzhen | Guangdong | 518000 | China |
| Affiliated Hospital of Guangdong Medical University | Zhanjiang | Guangdong | 524000 | China |
| The second affiliated hospital of guangxi medical university | Nanning | Guangxi | 530000 | China |
| Cangzhou Central Hospital | Cangzhou | Hebei | 061000 | China |
| The Fourth Hospital of Hebei Medical University | Shijiazhuang | Hebei | 50000 | China |
| Anyang Tumour Hospital | Anyang | Henan | 455000 | China |
| Henan Provincial People's Hospital | Zhengzhou | Henan | 450000 | China |
| Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology | Wuhan | Hubei | 430000 | China |
| Xiangya Hospital Central South University | Changsha | Hunan | 410000 | China |
| Jiangsu Province Hospital | Nanjing | Jiangsu | 210000 | China |
| Suzhou Municipal Hospital | Suzhou | Jiangsu | 215000 | China |
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | 215000 | China |
| The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | 330000 | China |
| The Second Affiliated Hospital Of Nanchang University | Nanchang | Jiangxi | 330000 | China |
| Bethune first hospital of jilin university | Changchun | Jilin | 130000 | China |
| China-Japan Union Hospital of JiLin University | Changchun | Jilin | 130000 | China |
| The Second Hospital of Dalian Medical University | Dalian | Liaoning | 116000 | China |
| Shengjing Hospital of China Medical University | Shenyang | Liaoning | 110000 | China |
| The First Hospital of China Medical University | Shenyang | Liaoning | 110000 | China |
| Affiliated Hospital of Chifeng University | Chifeng | Neimenggu | 24000 | China |
| The Affliated of Inner Mongolia Medical University | Hohhot | Neimenggu | 010000 | China |
| Qilu Hospital of Shandong Yniversity | Jinan | Shandong | 250000 | China |
| Shandong Cancer Hospital | Jinan | Shandong | 250000 | China |
| PKUCare Luzhong Hospital | Zibo | Shangdong | 255000 | China |
| Shanghai Jiaotong University Medical College Affiliated Ruijin hospital | Shanghai | Shanghai Municipality | 200000 | China |
| Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai Municipality | 200000 | China |
| ZhongShan Hospital | Shanghai | Shanghai Municipality | 200000 | China |
| Shanxi Provincial Cancer Hospital | Taiyuan | Shanxi | 030000 | China |
| West China Hospital of Sichuan University | Chengdu | Sichuang | 610000 | China |
| The Affliated of Southwest Medical University | Luzhou | Sichuang | 646000 | China |
| Tianjin Chest Hospital | Tianjin | Tianjin Municipality | 300000 | China |
| Tianjin Medical University General Hospital | Tianjin | Tianjin Municipality | 300000 | China |
| Sir Run Shaw Hospital Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310000 | China |
| The first affiliated hospital zhejiang university | Hangzhou | Zhejiang | 310000 | China |
| The Second Affiliated hospital of Zhejiang University Achool of Medical | Hangzhou | Zhejiang | 310000 | China |
| Zhejiang cancer hospital | Hangzhou | Zhejiang | 310000 | China |
| Ningbo Medical Center Lihuili Hospital | Ningbo | Zhejiang | 315000 | China |
| Shaoxing People's Hospital | Shaoxing | Zhejiang | 312000 | China |
| Taizhou Hospita of Zhejiang Province | Taizhou | Zhejiang | 318000 | China |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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