NCT06394037

Active Surveillance for Limited GGNs

Active Surveillance for Patients with Limited Ground-glass Nodules in China: a Prospective Multi-center Single-arm Trial (ECTOP-1028)

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 387 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a single-arm, multi-center, phase III trial conducted under the Eastern Cooperative Thoracic Oncoloy Project (ECTOP) . The primary objective of the study is to assess the 5-year overall survival of patients with one or two ground-glass opacities by employing an active surveillance approach rather than immediate surgical resection.

Detailed description

The trial aims to confirm the hypotheses that delaying surgery until GGO nodules exhibit progression or meet certain criteria offers a prognosis equivalent to those undergoing immediate surgical resection, potentially allowing many of these patients to avoid surgery altogether.

Conditions

• Lung Ground-glass Opacities
• Active Surveillance

Interventions

Type	Name	Description
PROCEDURE	Active surveillance	Conduct thoracic computed tomography scans every 12 months. If progression occurs, the treamtent approach would involve surgery.

Timeline

• Start date: 2025-05-01
• Primary completion: 2038-05-01
• Completion: 2038-05-01
• First posted: 2024-05-01
• Last updated: 2025-01-31

Locations

1 site across 1 country: China