Early Cancer Detection Test - Lung Cancer China

Study Overview
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Brief Summary
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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.

Official Title
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Clinic Validation of Autoantibody Panel for Lung Cancer Diagnosis in Chinese Population

Conditions
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Lung Cancer

Intervention / Treatment
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* Diagnostic Test: Tumor autoantibody detection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female aged 18 or above. Individuals complying with either of the following diagnosed as lung cancer (histopathologically confirmed); diagnosed as benign pulmonary nodule (confirmed by pathology or by follow-up based on 2018 Chinese Consensus on Pulmonary Nodule Diagnosis and Treatment); without pulmonary nodule but with lung cancer risk factor, age & gender matched recruited lung cancer patients. 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: History of any cancer; Lung cancer patient who received or is receiving any treatment, including but not limited to surgery, radiotherapy, chemotherapy, targeted therapy and immunotherapy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Case-Lung Cancer<br>Patients with definite lung cancer diagnosis | Diagnostic Test: Tumor autoantibody detection<br>* Level of a set of autoantibodies potentially relative with lung cancer will be tested for each of the participants.<br>|
| Control<br>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 | Diagnostic Test: Tumor autoantibody detection<br>* Level of a set of autoantibodies potentially relative with lung cancer will be tested for each of the participants.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tumor Autoantibody, Early Detection, Indeterminate Pulmonary Nodule