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A Registry for Patients With Multifocal Ground Glass Opacities (GGOs)

Sponsor
Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT03802981
Collaborator
M.D. Anderson Cancer Center (Other), Brigham and Women's Hospital (Other), Duke University (Other), Mayo Clinic (Other), Université de Montréal (Other), University of Pittsburgh (Other), University of Toronto (Other), Washington University School of Medicine (Other)
330
Enrollment
28
Locations
47.7
Anticipated Duration (Months)
11.8
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    330 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Thoracic Surgery Oncology Group (TSOG) Protocol: Registry Trial of Active Surveillance for Multifocal Ground Glass Opacities (GGOs)
    Actual Study Start Date :
    Jan 9, 2019
    Anticipated Primary Completion Date :
    Jan 1, 2023
    Anticipated Study Completion Date :
    Jan 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. lung cancer-specific survival [5 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stanford University Medical Center (Data collection only) Stanford California United States 94305-5408
    2 Hartford Healthcare Hartford Connecticut United States 06102
    3 Rush University Medical Center (Data collection only) Chicago Illinois United States 606012
    4 Massachusetts General Hospital Cancer Center Boston Massachusetts United States 02114
    5 Brigham and Women's Hospital Boston Massachusetts United States 02115
    6 University of Michigan Ann Arbor Michigan United States 48109
    7 Mayo Clinic Rochester Minnesota United States 55905
    8 George Washington University School of Medicine Saint Louis Missouri United States 63110
    9 Washington University School of Medicine Saint Louis Missouri United States 63110
    10 Memoral Sloan Kettering Basking Ridge Basking Ridge New Jersey United States 07920
    11 Memoral Sloan Kettering Monmouth Middletown New Jersey United States 07748
    12 Memorial Sloan Kettering Bergen Montvale New Jersey United States 07645
    13 Roswell Park Cancer Institute (Data Collection Only) Buffalo New York United States 14263-0001
    14 Memorial Sloan Kettering Commack Commack New York United States 11725
    15 Memoral Sloan Kettering Westchester Harrison New York United States 10604
    16 Memorial Sloan Kettering Cancer Center New York New York United States 10065
    17 Memorial Sloan Kettering Nassau Uniondale New York United States 11553
    18 Duke University Medical Center Durham North Carolina United States 27701
    19 Lehigh Valley Health Network Allentown Pennsylvania United States 18103
    20 University of Pennsylvania (Data Collection Only) Philadelphia Pennsylvania United States 19104
    21 Thomas Jefferson University Hospital Philadelphia Pennsylvania United States 19107
    22 Allegheny-Singer Research Institute Pittsburgh Pennsylvania United States 15212
    23 University of Pittsburgh Medical Center Pittsburgh Pennsylvania United States 15213
    24 MD Anderson Cancer Center Houston Texas United States 77030-4009
    25 Baylor University Medical Center Houston Texas United States 77030
    26 McMaster University (Data Collection Only) Hamilton Ontario Canada L8N 3Z5
    27 University Health Network Toronto Ontario Canada M5G 2C4
    28 Centre Hospitalier de l'Université de Montreal Montréal Quebec Canada H2L 4M1

    Sponsors and Collaborators

    • Memorial Sloan Kettering Cancer Center
    • M.D. Anderson Cancer Center
    • Brigham and Women's Hospital
    • Duke University
    • Mayo Clinic
    • Université de Montréal
    • University of Pittsburgh
    • University of Toronto
    • Washington University School of Medicine

    Investigators

    • Principal Investigator: James Huang, MD, Memorial Sloan Kettering Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Memorial Sloan Kettering Cancer Center
    ClinicalTrials.gov Identifier:
    NCT03802981
    Other Study ID Numbers:
    • 18-541
    First Posted:
    Jan 14, 2019
    Last Update Posted:
    Jul 25, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jul 25, 2022