Pulmonary nodules, benign pulmonary lesions, lung cancer, advanced NSCLC, EGFR-mutant advanced NSCLC and extensive-stage SCLC.
Conditions
Interventions
Gold Standard:Pathological diagnosis is confirmed with surgical or needle biopsy as the gold standard. Therapeutic efficacy is evaluated by imaging examinations including CT and MRI.
Index test:A prediction model for lung cancer based on exhaled breath and a treatment response model for advanced lung cancer (exhaled breath VOC mass spectrometry analysis).
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.(Part 1 ) Aged >= 18 years, no gender restriction; 2.(Part 1 ) Pulmonary nodules detected on chest computed tomography (CT), with clinical indications for biopsy or surgical resection; 3.(Part 1 ) Patients agree to undergo surgical resection or pathological biopsy for definitive diagnosis and sign written informed consent for exhaled breath sample collection; 4.(Part 1 ) Pathological confirmation of nodules as either benign lesions (e.g., inflammatory pseudotumor, granuloma, tuberculoma, benign neoplasm, etc.) or primary lung cancer (all major subtypes including adenocarcinoma, squamous cell carcinoma, SCLC, etc.). 5.(Part 2) Aged >= 18 years, no gender restriction. 6.(Part 2) Presence of measurable lesions eligible for treatment response assessment. 7.(Part 2) Histologically confirmed lung cancer; planned to receive standard first-line regimens: Cohort 1: platinum-based doublet chemotherapy combined with PD-1 inhibitor; Cohort 2: single-agent EGFR-TKI; Cohort 3: platinum-based doublet chemotherapy with or without immunotherapy. 8.(Part 2) Eastern Cooperative Oncology Group (ECOG) performance status score of 0–2. 9.(Part 2) No other concurrent active malignancies.
Exclusion criteria
Exclusion criteria: 1.(Part 1 )Concurrent active malignant tumors of other origins. 2.(Part 1 )Severe pulmonary infection or other conditions that may alter exhaled breath composition. 3.(Part 1 )Prior anti-tumor therapies (chemotherapy, radiotherapy, etc.) before surgery which could modify tumor metabolism. 4.(Part 1 )Any other conditions rendering patients unfit for exhaled breath sampling. 5.(Part 2)Previous history of systematic anti-cancer treatment (chemotherapy, immunotherapy or targeted therapy). 6.(Part 2)Severe comorbidities interfering with breath VOC profiles (e.g., active pulmonary infection, severe diabetic ketoacidosis). 7.(Part 2)Inability to complete regular follow-up and scheduled breath collection. 8.(Part 2)Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Specificity;Accuracy;Area Under the Curve;positive predictive value;Negative predictive value ; | — |
Countries
China
Contacts
Public ContactYayi He
Shanghai Pulmonary Hospital
Outcome results
None listed