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The Cohort Study on the Molecular Pathological Characteristics and Tumor Immune Microenvironment of Airway Spread Through Air Spaces (STAS) in Non-Small Cell Lung Cancer

The Cohort Study on the Molecular Pathological Characteristics and Tumor Immune Microenvironment of Airway Spread Through Air Spaces (STAS) in Non-Small Cell Lung Cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500096472
Enrollment
Unknown
Registered
2025-01-24
Start date
2025-01-25
Completion date
Unknown
Last updated
2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small cell lung cancer

Interventions

STAS-positive group:None
STAS-negative group:None

Sponsors

Shanghai Chest Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Age range from 18 to 90 years old, gender not specified. 2. Preoperative assessment confirms resectable lesions. 3. Underwent robot-assisted, thoracoscopic, or traditional open-chest lung surgery, with pathology confirming NSCLC. 4. ECOG performance status score of 0-1. 5. Good organ function. 6. Willing and able to comply with the study protocol's visits, treatment schedules, laboratory tests, and other research procedures.

Exclusion criteria

Exclusion criteria: 1. Pathology includes malignant tumors or benign lesions of other types or undetermined types; 2. Patients with clinical or pathological stage IV; 3. Uncertain whether STAS (Spread Through Air Spaces) has occurred; 4. Patients who have not undergone tumor molecular pathology and PD-L1 expression testing; 5. Patients who have received any preoperative induction therapy; 6. Known history of active tuberculosis; 7. Known active infection requiring systemic treatment; 8. Patients with any known or suspected autoimmune disease or immune deficiency, except: patients with a history of hypothyroidism, if no hormone therapy is needed or if receiving physiological dose hormone replacement therapy; patients with stable type I diabetes with controlled blood glucose levels; 9. Uncontrolled active hepatitis B (defined as a positive hepatitis B surface antigen [HBsAg] test result at the screening period with HBV-DNA levels above the upper limit of normal for the study center’s laboratory); 10. (Patients with HBV-DNA levels < 500 IU/mL who have received at least 14 days of standard local antiviral therapy and are willing to continue antiviral therapy during the study period can be enrolled); active hepatitis C (defined as a positive hepatitis C surface antibody [HCsAb] test result at the screening period, HCV-RNA positive); 11. Known human immunodeficiency virus (HIV) infection (known HIV antibody positive); 12. Vaccination with a live vaccine within 30 days before surgery. This includes, but is not limited to: mumps, rubella, measles, varicella/zoster (chickenpox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine (inactivated virus vaccines are permitted); 13. Known severe or uncontrolled underlying diseases; including but not limited to hemodynamically unstable cardiovascular events within the past 6 months, symptomatic cerebrovascular events, cirrhosis with Child-Pugh grade above A; 14. According to the investigator’s judgment, patients with any disease, treatment, or laboratory abnormality that may confuse the study results or are not in the best interest of the patient to participate in the study.

Design outcomes

Primary

MeasureTime frame
PD-L1 Expression in Tumor Cells;Proportion of High-Risk Pathological Factors in Tumors (Solid and Micropapillary Components);

Secondary

MeasureTime frame
Tumor Pleural Invasion (PL0/PL1/PL2);Tumor Driver Gene Mutations (EGFR, ALK, KRAS);

Countries

China

Contacts

Public ContactQINGQUAN LUO

Shanghai Chest Hospital

luoqingquan@hotmail.com+86 130 0324 7676

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026