Registry Trial of Active Surveillance for Multifocal Ground Glass Opacities (GGOs) (H-47241)

Objective:

The primary objective is to determine lung cancer–specific survival at 5 years among patients undergoing active surveillance for GGOs.

Design:

Registry trial enrolling patients with two or more GGOs identified on CT imaging. Patients will have all qualifying GGOs cataloged and will be enrolled in a program of active surveillance with chest CT scan every 6-12 months.

Subject Inclusion Criteria:

• Age greater than 18 years
• Have two or more GGOs on initial CT imaging
• GGOs must measure ≤3.0 cm and ≥0.6 cm in the greatest dimension
• GGOs must be greater than half ground glass

A biopsy is not necessary for inclusion in the trial. Biopsy of a GGO, even with a diagnosis of adenocarcinoma, does not necessarily preclude enrollment in this surveillance protocol. In other words, patients with a diagnosis of adenocarcinoma are still eligible, at the discretion of the clinician and/or investigator, if they meet the above criteria.

Subject Exclusion Criteria:

• Patients who are actively undergoing lung cancer treatment or have a history of lung cancer, except for cases of completely resected pathologic stage IA non-small cell lung cancer (NSCLC). Patients with stage IA NSCLC and multiple GGOs can enroll in this active surveillance protocol after complete resection or definitive radiation therapy of the NSCLC. These patients can be enrolled immediately after confirmation of stage on final pathologic assessment if they otherwise have no evidence of disease.
• The presence of any solid lesion ≥0.6 cm suspicious for malignancy
• Patients who are actively undergoing treatment for other malignancies