Active Surveillance for Limited GGNs

NCT06394037 | Not Yet Recruiting

• 1 other identifier: ECTOP-1028
• Study Type: observational
• Target: 387
• 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) . 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.

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

Secondary Outcomes (1)

• 10-year overall survival

  10 years

Study Arms (1)

Observation

Active surveillance

Procedure: Active surveillance

Interventions

Active surveillance PROCEDURE

Conduct thoracic computed tomography scans every 12 months. If progression occurs, the treamtent approach would involve surgery.

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 visiting the hospitals/medical centers.

Patients eligible for enrollment in the study are required to meet all the following criteria. 1. Demonstrates the following on thin-section computed tomography (TSCT) scan: 1. Presence of one or two GGNs (bilateral lesions are permitted). 2. All lesions have remained stable without regression or enlargement for at least 3 months. 3. The dominant lesion (the lesion with the largest maximum tumor diameter) has a maximum tumor diameter ≥0.6cm and ≤2cm. 4. CTR ≤0.25 in lesions. 5. No lymph node with a diameter \>1cm in the mediastinal view. 6. Not adjacent to the pleura in dominant lesion and no sign of pleural retraction in any lesions. 2. Has not previously undergo any anti-tumor drug or radiation therapy for the lung lesions. 3. Aged 18-75 years. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 5. Written informed consent. Patients will be excluded if they meet any of the following criteria. 1. History of any prior malignancies within the past 5 years. 2. History of lung surgery. 3. History of interstitial pneumonia, pulmonary fibrosis or other severe pulmonary diseases. 4. Presence of severe or uncontrolled diseases that may possibly reduce the 10-year life expectancy.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

Location

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

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: April 27, 2024
• First Posted: May 1, 2024
• Study Start: May 1, 2025
• Primary Completion (Estimated): May 1, 2038
• Study Completion (Estimated): May 1, 2038
• 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)