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

Primary Investigator
Lin, Jules
Status
OPEN TO ACCRUAL
Phase
NA
NCT Number
NCT03802981
UM Number
00172844
Age Group
Adults
Management Group
CTSU - Oncology
Oncology Group
Thoracic Oncology
ID (Protocol)
41115
Secondary Protocol No
HUM00172844
Scope
Unspecified
Sponsor Type
Industry
Disease Site
Lung
Summary
The purpose of this registry study is to actively monitor people with GGOs and collect information about them, so that investigators can learn more about these lesions and about the risk of developing lung cancer in study participants whose GGOs are being monitored in the active surveillance program.

Eligibility: Inclusion Criteria
    •   Age greater than 18 years
    •   Have two or more GGOs on initial CT imaging
    •   GGOs must be 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.
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 nonsmall cell lung cancer (NSCLC). Patients with stage IA NSCLC and multiple GGOs can enroll in this active surveillance protocol after complete resection of the NSCLC and confirmation of stage on final pathologic assessment.
    •   The presence of any solid lesion >=0.6 cm suspicious for malignancy.
    •   Patients who are actively undergoing treatment for other malignancies