A Registry for Patients With Multifocal Ground Glass Opacities (GGOs)
Thoracic Surgery Oncology Group (TSOG) Protocol: Registry Trial of Active Surveillance for Multifocal Ground Glass Opacities (GGOs)
Study Overview
Status
Status
Conditions
Conditions
Study Type
Study Type
Enrollment (Actual)
Enrollment
Contacts and Locations
Study Contact
Study Contact
- Name: James Huang, MD
- Phone Number: 212-639-2530
- Email: huangj@mskcc.org
Study Contact Backup
- Name: David R Jones, MD
- Phone Number: 212-639-6428
Study Locations
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Ontario
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Hamilton, Ontario, Canada, L8N 3Z5
- McMaster University (Data Collection Only)
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Toronto, Ontario, Canada, M5G 2C4
- University Health Network
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Quebec
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Montreal, Quebec, Canada, H2L 4M1
- Centre Hospitalier de l'Université de Montréal
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California
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San Diego, California, United States, 92103
- University of California San Diego
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Stanford, California, United States, 94305-5408
- Stanford University Medical Center (Data collection only)
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Connecticut
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Hartford, Connecticut, United States, 06102
- Hartford Healthcare
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Illinois
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Chicago, Illinois, United States, 606012
- Rush University Medical Center (Data collection only)
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital Cancer Center
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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Missouri
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St Louis, Missouri, United States, 63110
- Washington University School of Medicine
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St Louis, Missouri, United States, 63110
- George Washington University School of Medicine
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New Jersey
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Basking Ridge, New Jersey, United States, 07920
- Memorial Sloan Kettering Basking Ridge
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Middletown, New Jersey, United States, 07748
- Memorial Sloan Kettering Monmouth
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Montvale, New Jersey, United States, 07645
- Memorial Sloan Kettering Bergen
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New York
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Buffalo, New York, United States, 14263-0001
- Roswell Park Cancer Institute (Data Collection Only)
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Commack, New York, United States, 11725
- Memorial Sloan Kettering Commack
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Harrison, New York, United States, 10604
- Memorial Sloan Kettering Westchester
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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New York, New York, United States, 10065
- New York Presbyterian Hospital
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Uniondale, New York, United States, 11553
- Memorial Sloan Kettering Nassau
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North Carolina
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Durham, North Carolina, United States, 27701
- Duke University Medical Center
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Pennsylvania
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Allentown, Pennsylvania, United States, 18103
- Lehigh Valley Health Network
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Philadelphia, Pennsylvania, United States, 19111
- Fox Chase Cancer Center
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Philadelphia, Pennsylvania, United States, 19107
- Thomas Jefferson University Hospital
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Philadelphia, Pennsylvania, United States, 19140
- Temple University
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania (Data Collection Only)
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Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh Medical Center
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Pittsburgh, Pennsylvania, United States, 15212
- Allegheny Health Network
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Texas
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Houston, Texas, United States, 77030
- Baylor University Medical Center
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Houston, Texas, United States, 77030-4009
- Md Anderson Cancer Center
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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lung cancer-specific survival
Time Frame: 5 years
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5 years
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Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: James Huang, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- 18-541
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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