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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03802981
Recruitment Status : Recruiting
First Posted : January 14, 2019
Last Update Posted : August 20, 2021
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
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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
Multiple Ground Glass Opacities (GGOs)

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 330 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Thoracic Surgery Oncology Group (TSOG) Protocol: Registry Trial of Active Surveillance for Multifocal Ground Glass Opacities (GGOs)
Actual Study Start Date : January 9, 2019
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Primary Outcome Measures :
  1. lung cancer-specific survival [ Time Frame: 5 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03802981

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Contact: James Huang, MD 212-639-2530
Contact: David R Jones, MD 212-639-6428

Show Show 27 study locations
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
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Principal Investigator: James Huang, MD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center Identifier: NCT03802981    
Other Study ID Numbers: 18-541
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: August 20, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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 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:
Supporting Materials: Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No