Active Surveillance for Limited GGNs

Launched by FUDAN UNIVERSITY · Apr 27, 2024

Keywords

ClinConnect Summary

This clinical trial, called "Active Surveillance for Limited GGNs," is looking at a different approach to managing certain lung conditions known as ground-glass opacities (GGNs). Instead of immediately performing surgery to remove these small areas in the lungs, the study aims to see how well patients do over five years when monitored closely without surgery. This method, called active surveillance, could be beneficial for patients with one or two stable GGNs that have not changed in size for at least three months.

To participate in the trial, individuals must be between 18 and 75 years old and have specific characteristics in their lung scans—like having GGNs that are stable and not too large. They should also be in good health overall, without a history of major lung diseases or previous cancer treatments. If you or someone you know fits these criteria, joining this study could provide important insights into the management of GGNs while allowing for regular monitoring instead of immediate surgery. Participants in the trial will be closely observed over the study period, which may help doctors learn more about the best ways to care for patients with these lung conditions.

Gender

ALL

Eligibility criteria

• • 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.