Plasma Proteomic Biomarkers for Early Diagnosis of Lung Cancer

Study Overview
=================
Brief Summary
-----------------
We will identify plasma proteomics biomarkers for early diagnosis of lung cancer.

Detailed Description
-----------------
We will use TMT-based proteomics approaches to analyze more than 2000 proteins in plasma samples from lung cancer patients and controls. Artificial intelligent (AI) assisted proteomics classifier will be developed for early diagnosis of lung cancer.

Official Title
-----------------
Identification and Functional Verification Study in Plasma Proteomic Biomarkers for Early Diagnosis of Lung Cancer

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Other: Plasma protein biomarker analysis
* Other: Plasma protein biomarker analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CT screening results showed that the size of pulmonary nodules was more than 5mm No treatment related to pulmonary nodules/lung cancer (including surgery, chemotherapy, radiotherapy, targeted therapy, immunotherapy, interventional therapy, etc.) Complete clinical and imaging data Chest CT/ low-dose spiral CT reports can be provided in the last 3 months Voluntarily sign informed consent Exclusion Criteria: There is a history of tumor Clinically uncontrolled active infections, such as acute pneumonia, tuberculosis, etc. Received any treatment related to pulmonary nodules, such as antibiotics and hormones, in the past 4 weeks Complicated with other tumors and serious diseases of the heart, liver, kidney, brain, blood and other systems Participated in other clinical trials within the last 3 months Combined with liver and kidney insufficiency, hypoproteinemia and other diseases affecting protein content You are pregnant or breastfeeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lung cancer group<br>Patients age over 18, with confirmed diagnosis of lung cancer. | Other: Plasma protein biomarker analysis<br>* Plasma samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment.We will use TMT-based proteomics approaches to analyze more than 2000 proteins in plasma samples from lung cancer patients .<br>|
| Control group<br>Non-cancer patients including healthy volunteers, chronic inflammatory airway diseases such as chronic obstructive airway disease, asthma, and bronchiectasis, etc. | Other: Plasma protein biomarker analysis<br>* Plasma samples of control subjects were collected.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma proteomic biomarkers | Plasma proteomic biomarkers for detection of lung cancer | 1 month after surgery | 
| Model or classifier performance | Artificial intelligent (AI) assisted proteomics classifier will be developed for early diagnosis of lung cancer; and model or classifier performance including AUC, sensitivity, specificity, and accuracy | 1 month after surgery |