Surveillance for Multifocal GGNs

NCT06097910 | Recruiting

• 1 other identifier: ECTOP-1021
• Study Type: observational
• Target: 370
• Locations: 1 country
• Sites: 1

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 active surveillance approach rather than opting for surgical resection.

Conditions

Lung Ground-glass Opacities; Active Surveillance

Outcome Measures

Primary Outcomes (1)

• 5-year overall survival

  The event is defined as the death due to any causes.

  5 years

Study Arms (1)

Observation

Procedure: Watchful waiting

Interventions

Watchful waiting PROCEDURE

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.

Observation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Outpatients who are willing to particiapte in the study and meet the inclusion and exculsion criteria.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Interventions

Watchful Waiting

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Central Study Contacts

Haoxuan Wu, Dr.

CONTACT

86-021-64175590; haoxuanwu@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director in the Department of Thoracic Surgery, FUSCC

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: October 24, 2023
• Study Start: November 1, 2023
• Primary Completion (Estimated): November 1, 2036
• Study Completion (Estimated): November 1, 2036
• Last Updated: January 31, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Within five years from the study end.
• Access Criteria: Medical oncologists and surgeons who are interested in the study. Emails could be sent to the address below to obtain the shared data: hqchen1@yahoo.com

Locations

CN (1)