Active Surveillance for Limited GGNs

Not yet recruiting

• Conditions: Lung Ground-glass Opacities; Active Surveillance
• Interventions: Procedure: Active surveillance

• Registration Number: NCT06394037
• Lead Sponsor: Fudan University

Brief 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.

Study Timeline

• Study First Submitted: 2024-04-27
• Study First Submitted QC: 2024-04-27
• Study First Posted: 2024-05-01
• Status Verified: 2024-09
• Last Update Submitted: 2025-01-29
• Last Update Posted: 2025-01-31
• Study Start: 2025-05-01
• Primary Completion: 2038-05-01
• Study Completion: 2038-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 387

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observation	Active surveillance	Active surveillance

Primary Outcome Measures

Name	Time	Method
5-year overall survival	5 years	The event is defined as the death due to any causes.

Secondary Outcome Measures

Name	Time	Method
10-year overall survival	10 years	The event is defined as the death due to any causes.

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, China