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Recruiting NCT06097910

Surveillance for Multifocal GGNs

— Observational Lung Ground-glass Opacities Active Surveillance

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Watchful waiting.
Who it may be relevant to
Registry conditions: Lung Ground-glass Opacities, Active Surveillance. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Active Surveillance for Patients with Multifocal Ground-glass Nodules: a Prospective, Multi-center, Single-arm Trial (ECTOP-1021)

Overview

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 active surveillance 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.

Interventions

  • Procedure Watchful waiting
    Conduct thoracic computed tomography scans every 12 months. The decision regarding surgery is based on the surgeon's evaluation of radiologic follow-up. The reference resection criteria encompass: a) Any lesion that progresses to a tumor diameter larger than 2cm or has CTR greater than 0.25. b) Clinical Tumor, node, metastasis (TNM) stage upstaging.

Primary outcome measures

  • 5-year overall survival [Time frame: 5 years]

Eligibility criteria

Inclusion criteria Patients eligible for enrollment in the study are required to meet all the following criteria.

  • Demonstrates the following on thin-section computed tomography (TSCT) scan:
  • Presence of three or more GGNs (bilateral lesions are permitted).
  • All lesions have remained stable without regression or enlargement for at least 3 months.
  • The dominant lesion (the lesion with the largest maximum tumor diameter) has a maximum tumor diameter >=0.6cm and <=2cm.
  • CTR <=0.25 in all lesions.
  • No lymph node with a diameter >1cm in the mediastinal view.
  • Not adjacent to the pleura in dominant lesion and no sign of pleural retraction in any lesions.
  • Aged 18-75 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Has not previously undergo any anti-tumor drug or radiation therapy.
  • Written informed consent.

Exclusion criteria Patients will be excluded if they meet any of the following criteria.

  • History of any prior malignancies within the past 5 years.
  • History of lung surgery.
  • History of interstitial pneumonia, pulmonary fibrosis or other severe pulmonary diseases.
  • Presence of severe or uncontrolled diseases that may possibly reduce the 10-year life expectancy.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Fudan University Cancer Center — Shanghai

Publications

  • Wu H, Fu F, Ye T, Hu H, Yu Q, Zhang H, Jiang F, Song Q, Ma J, Hei T, Cheng Y, Gong M, Wang S, Gu Y, Li Y, Wu W, Zhang Y, Chen H. Active Surveillance of Multifocal Ground-Glass Opacities: Results of a Prospective Multicenter Trial (ECTOP1021). J Thorac Oncol. 2026 Jan;21(1):150-159. doi: 10.1016/j.jtho.2025.09.011. Epub 2025 Sep 20. PMID 40983284
  • Wu H, Deng P, Fu F, Zhang Y, Chen H. Active surveillance for patients with multifocal ground-glass nodules: protocol of a prospective, multi-center, single-arm trial (ECTOP-1021). J Thorac Dis. 2025 Apr 30;17(4):2634-2639. doi: 10.21037/jtd-2024-1956. Epub 2025 Apr 28. PMID 40400915

Identifiers

NCT: NCT06097910 · ECTOP-1021

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗