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)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Multiple Ground Glass Opacities (GGOs)

• Study Type: Observational
• Enrollment (Actual): 338

Contacts and Locations

• 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

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N 3Z5
      • McMaster University (Data Collection Only)
    • Toronto, Ontario, Canada, M5G 2C4
      • University Health Network
  • Quebec
    • Montréal, Quebec, Canada, H2L 4M1
      • Centre Hospitalier de l'Universite de Montreal
• United States
  • California
    • San Diego, California, United States, 92103
      • University of California San Diego
    • Stanford, California, United States, 94305-5408
      • Stanford University Medical Center (Data collection only)
  • Connecticut
    • Hartford, Connecticut, United States, 06102
      • Hartford Healthcare
  • Illinois
    • Chicago, Illinois, United States, 606012
      • Rush University Medical Center (Data collection only)
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital Cancer Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
    • Saint Louis, Missouri, United States, 63110
      • George Washington University School of Medicine
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Memorial Sloan Kettering Basking Ridge
    • Middletown, New Jersey, United States, 07748
      • Memorial Sloan Kettering Monmouth
    • Montvale, New Jersey, United States, 07645
      • Memorial Sloan Kettering Bergen
  • New York
    • Buffalo, New York, United States, 14263-0001
      • Roswell Park Cancer Institute (Data Collection Only)
    • Commack, New York, United States, 11725
      • Memorial Sloan Kettering Commack
    • Harrison, New York, United States, 10604
      • Memorial Sloan Kettering Westchester
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
    • New York, New York, United States, 10065
      • New York Presbyterian Hospital
    • Uniondale, New York, United States, 11553
      • Memorial Sloan Kettering Nassau
  • North Carolina
    • Durham, North Carolina, United States, 27701
      • Duke University Medical Center
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Lehigh Valley Health Network
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase Cancer Center
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University Hospital
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania (Data Collection Only)
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny Health Network
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor University Medical Center
    • Houston, Texas, United States, 77030-4009
      • MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

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

Outcome Measure	Time Frame
lung cancer-specific survival	5 years

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: M.D. Anderson Cancer Center; Mayo Clinic; Washington University School of Medicine; University of Pittsburgh; Duke University; Brigham and Women's Hospital; University of Toronto; Université de Montréal
• Investigators: Principal Investigator: James Huang, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2019
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: January 9, 2019
• First Submitted That Met QC Criteria: January 10, 2019
• First Posted (Actual): January 14, 2019

Study Record Updates

• Last Update Posted (Actual): December 14, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 18-541

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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: crdatashare@mskcc.org.
• IPD Sharing Supporting Information Type: SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No