Plasma Proteomic Biomarkers for Early Diagnosis of Lung Cancer

Active, not recruiting

• Conditions: Lung Cancer
• Interventions: Other: Plasma protein biomarker analysis

• Registration Number: NCT05742204
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Study Timeline

• Study Start: 2023-02-01
• Study First Submitted: 2023-02-15
• Study First Submitted QC: 2023-02-15
• Study First Posted: 2023-02-23
• Status Verified: 2025-05
• Primary Completion: 2025-05-01
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-15
• Study Completion: 2032-10-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 3700

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control group	Plasma protein biomarker analysis	Non-cancer patients including healthy volunteers, chronic inflammatory airway diseases such as chronic obstructive airway disease, asthma, and bronchiectasis, etc.
Lung cancer group	Plasma protein biomarker analysis	Patients age over 18, with confirmed diagnosis of lung cancer.

Primary Outcome Measures

Name	Time	Method
Plasma proteomic biomarkers	1 month after surgery	Plasma proteomic biomarkers for detection of lung cancer
Model or classifier performance	1 month after surgery	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

Trial Locations

Locations (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University; 🇨🇳 Hangzhou, China