A Registry for Patients With Multifocal Ground Glass Opacities (GGOs)
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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.
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Layout table for eligibility information
Ages Eligible for Study:
19 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients with GGOs or mixed subsolid pulmonary nodules may be recruited from participating Thoracic Oncology Surgical Group (TSOG) sites, in accordance with local institutional practice and referral patterns, and assessed for eligibility based on the criteria listed below.
Age greater than 18 years
Have two or more GGOs on initial CT imaging
GGOs must be measure ≤30 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 clinical and/or investigator, if they meet the above criteria.
Any GGO that measures <0.6 cm does not need to be followed. At follow-up visits, any new GGO's that meet the eligibility criteria will be captured and followed. Additionally, any pre-existing GGO's that have grown to a size of ≥0.6 cm will be catalogued and followed as well.
Patients who are actively undergoing lung cancer treatment or have a history of such treatment, 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.
Patients being actively treated for other malignancies (not including lung cancer) or who have previously been treated for other malignancies and have been cancer-free for <3 years before study registration, other than non-melanoma skin cancer, superficial bladder cancer, or CIS of the cervix.
The presence of any solid lesion ≥0.6 cm on initial chest CT scan imaging
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: firstname.lastname@example.org.
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)