Multiple Ground Glass Opacities (GGOs) Clinical Trial
Official title:
Thoracic Surgery Oncology Group (TSOG) Protocol: Registry Trial of Active Surveillance for Multifocal Ground Glass Opacities (GGOs)
| Verified date | May 2024 |
| Source | Memorial Sloan Kettering Cancer Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
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.
| Status | Active, not recruiting |
| Enrollment | 338 |
| Est. completion date | January 2026 |
| Est. primary completion date | January 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 19 Years and older |
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| Canada | McMaster University (Data Collection Only) | Hamilton | Ontario |
| Canada | Centre Hospitalier de l'Université de Montreal | Montréal | Quebec |
| Canada | University Health Network | Toronto | Ontario |
| United States | Lehigh Valley Health Network | Allentown | Pennsylvania |
| United States | University of Michigan | Ann Arbor | Michigan |
| United States | Memorial Sloan Kettering Basking Ridge | Basking Ridge | New Jersey |
| United States | Brigham and Women's Hospital | Boston | Massachusetts |
| United States | Massachusetts General Hospital Cancer Center | Boston | Massachusetts |
| United States | Roswell Park Cancer Institute (Data Collection Only) | Buffalo | New York |
| United States | Rush University Medical Center (Data collection only) | Chicago | Illinois |
| United States | Memorial Sloan Kettering Commack | Commack | New York |
| United States | Duke University Medical Center | Durham | North Carolina |
| United States | Memorial Sloan Kettering Westchester | Harrison | New York |
| United States | Hartford Healthcare | Hartford | Connecticut |
| United States | Baylor University Medical Center | Houston | Texas |
| United States | MD Anderson Cancer Center | Houston | Texas |
| United States | Memorial Sloan Kettering Monmouth | Middletown | New Jersey |
| United States | Memorial Sloan Kettering Bergen | Montvale | New Jersey |
| United States | Memorial Sloan Kettering Cancer Center | New York | New York |
| United States | New York Presbyterian Hospital | New York | New York |
| United States | Fox Chase Cancer Center | Philadelphia | Pennsylvania |
| United States | Temple University | Philadelphia | Pennsylvania |
| United States | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania |
| United States | University of Pennsylvania (Data Collection Only) | Philadelphia | Pennsylvania |
| United States | Allegheny Health Network | Pittsburgh | Pennsylvania |
| United States | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
| United States | Mayo Clinic | Rochester | Minnesota |
| United States | George Washington University School of Medicine | Saint Louis | Missouri |
| United States | Washington University School of Medicine | Saint Louis | Missouri |
| United States | University of California San Diego | San Diego | California |
| United States | Stanford University Medical Center (Data collection only) | Stanford | California |
| United States | Memorial Sloan Kettering Nassau | Uniondale | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Memorial Sloan Kettering Cancer Center | Brigham and Women's Hospital, Duke University, M.D. Anderson Cancer Center, Mayo Clinic, Université de Montréal, University of Pittsburgh, University of Toronto, Washington University School of Medicine |
United States, Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | lung cancer-specific survival | 5 years |