Staging Strategies and Their Association With Prognosis and Therapy in Lung Cancer With Cystic Airspaces

NCT07066813 | Recruiting

• 1 other identifier: LYEC2025-K0017
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to determine the most accurate tumor size measurement method for T-staging and prognostic assessment in lung cancer with cystic airspaces (LCCA). The main questions it aims to answer are:

• What is the optimal T-staging approach for accurately classifying lung cancer with cystic airspaces （LCCA) and predicting patient outcomes?
• How do imaging features of cystic lesions correlate with their pathological characteristics?
• What is the relationship between imaging features of cystic airspace-associated lesions and patient prognosis?
• Can optimizing the T-staging method improve clinical decision-making in patients with LCCA?

Conditions

Lung Cancer Associated With Cystic Airspaces

Outcome Measures

Primary Outcomes (2)

• DFS

  Disease-Free Survival

  From enrollment to the end of surgery for 5 years

• OS

  Overall Survival

  From enrollment to the end of surgery for 5 years

Secondary Outcomes (5)

• Rate of T-stage reclassification

  From enrollment to the end of surgery for 5 years

• AI-based extraction of radiologic characteristics of cystic airspace-associated lesions

  From enrollment to the end of surgery for 5 years

• AI to extract and analyze pathological features

  From enrollment to the end of surgery for 5 years

• Oncogenic driver genetic alterations

  From enrollment to the end of surgery for 5 years

• Receipt of postoperative adjuvant therapy

  From enrollment to the end of surgery for 5 years

Study Arms (3)

group 1

radiologic T stage based on the maximum tumor diameter including cystic components

group 2

radiologic T stage based on the diameter of the solid/invasive portion only

group 3

pathologic T stage derived from the resected specimen

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with LCCA who underwent surgical treatment in the Second Xiangya Hospital of Central South University

You may qualify if:

• Histologically confirmed non-small cell lung cancer (NSCLC), as verified by biopsy or postoperative pathological examination;
• Patients who have undergone surgical lung resection;
• Patients with complete preoperative chest CT imaging data;
• Preoperative chest CT showing a well-defined gas-containing (air-filled) cystic component within the tumor.

You may not qualify if:

• History of pulmonary diseases that could produce cystic lung lesions (e.g., tuberculosis, pulmonary fungal infections, bullae, emphysema, Lymphangioleiomyomatosis \[LAM\], or Birt-Hogg-Dubé \[BHD\] syndrome);
• Systemic anti-tumor therapies, including chemotherapy, radiotherapy, or targeted therapies (such as monoclonal antibodies, small-molecule tyrosine kinase inhibitors, among others), were administered prior to enrollment;
• Patients with concurrent other malignancies;
• Patients with missing or poor-quality preoperative chest CT imaging data.

Sponsors & Collaborators

• Central South University: lead

Study Sites (1)

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

RECRUITING

Central Study Contacts

Chen Chen

CONTACT

+8673185295188; chenchen1981412@csu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 5, 2025
• First Posted: July 15, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)