Surveillance for Multifocal GGNs

Recruiting

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

• Registration Number: NCT06097910
• 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) with the identification number ECTOP-1021. The primary objective of the study is to assess the overall survival of patients with multifocal ground-glass opacities by employing a watchful waiting approach rather than opting for 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. Surgical criteria are met if any of the lesions exhibit progression (with a maximal diameter increase of more than 1.5mm or the apperance of a solid component) or as determined by each institution.

Study Timeline

• Study First Submitted: 2023-10-19
• Study First Submitted QC: 2023-10-19
• Study First Posted: 2023-10-24
• Study Start: 2023-11-01
• Status Verified: 2024-09
• Last Update Submitted: 2025-01-29
• Last Update Posted: 2025-01-31
• Primary Completion: 2036-11-01
• Study Completion: 2036-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 370

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observation	Watchful waiting	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Fudan University Cancer Center; 🇨🇳 Shanghai, Shanghai, China