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| Name | Class |
|---|---|
| Gene Tech (Shanghai) Company Limited | UNKNOWN |
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Lung cancer is the most common cancer in China from both incidence and mortality rate point of view, with significantly lower 5-year survival rate than average. Early detection is the recognized solution. LDCT is more and more popular accepted as an effective screening methodology but leads to numerous indeterminate pulmonary nodules for physicians to distinguish too. The value of autoantibody test in risk assessing of IPNs as well as early detection of lung cancer in high risk population has been demonstrated in clinical practice and trial but mainly in Caucasian. Purpose of this study is to understand the sensitivity, specificity and accuracy of candidate autoantibodies, and consequently explore the autoantibody combination with best clinical performance in Chinese population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Case-Lung Cancer | Patients with definite lung cancer diagnosis |
| |
| Control | Either patients with benign pulmonary nodule, or healthy individuals without pulmonary nodule but with risk factors to develop lung cancer matched to lung cancer group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tumor autoantibody detection | Diagnostic Test | Level of a set of autoantibodies potentially relative with lung cancer will be tested for each of the participants. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Autoantibody panel with best clinical performance in Chinese population | The combination which can achieve best sensitivity at 90% specificity, and its sensitivity, accuracy and PPV. | Oct.30, 2020 |
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Inclusion Criteria:
Male or female aged 18 or above.
Individuals complying with either of the following
Participant is willing and able to provide necessary information required in CRF.
Participant is willing and able to give informed consent for participation in the study.
Exclusion Criteria:
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Individuals diagnosed with lung cancer, benign pulmonary nodule or identified as at-risk healthy volunteer in participating hospitals of this study, from the recruitment starting date, till the end of the study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chunxue Bai, MD | Contact | 18621170011 | bai.chunxue@zs-hospital.sh.cn | |
| Jian Zhou, MD | Contact | 18221223320 | zhou.jian@fudan.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Chunxue Bai, MD | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital of Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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serum or plasma
| Shanghai Chest Hospital | Recruiting | Shanghai | China |
|
| Henan Province People's Hospital | Not yet recruiting | Zhengzhou | China |
|
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |