<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03802981</url>
  </required_header>
  <id_info>
    <org_study_id>18-541</org_study_id>
    <nct_id>NCT03802981</nct_id>
  </id_info>
  <brief_title>A Registry for Patients With Multifocal Ground Glass Opacities (GGOs)</brief_title>
  <official_title>Thoracic Surgery Oncology Group (TSOG) Protocol: Registry Trial of Active Surveillance for Multifocal Ground Glass Opacities (GGOs)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Memorial Sloan Kettering Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Brigham and Women's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Université de Montréal</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Toronto</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Memorial Sloan Kettering Cancer Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this registry study is to actively monitor people with GGOs and collect&#xD;
      information about them, so that investigators can learn more about these lesions and about&#xD;
      the risk of developing lung cancer in study participants whose GGOs are being monitored in&#xD;
      the active surveillance program.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 9, 2019</start_date>
  <completion_date type="Anticipated">January 2024</completion_date>
  <primary_completion_date type="Anticipated">January 2024</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>lung cancer-specific survival</measure>
    <time_frame>5 years</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">330</enrollment>
  <condition>Multiple Ground Glass Opacities (GGOs)</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with GGOs or mixed subsolid pulmonary nodules may be recruited from participating&#xD;
        Thoracic Oncology Surgical Group (TSOG) sites, in accordance with local institutional&#xD;
        practice and referral patterns, and assessed for eligibility based on the criteria listed&#xD;
        below.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age greater than 18 years&#xD;
&#xD;
          -  Have two or more GGOs on initial CT imaging&#xD;
&#xD;
          -  GGOs must be measure ≤3.0 cm and ≥0.6 cm in the greatest dimension&#xD;
&#xD;
          -  GGOs must be greater than half ground glass&#xD;
&#xD;
        A biopsy is not necessary for inclusion in the trial. Biopsy of a GGO, even with a&#xD;
        diagnosis of adenocarcinoma, does not necessarily preclude enrollment in this surveillance&#xD;
        protocol. In other words, patients with a diagnosis of adenocarcinoma are still eligible,&#xD;
        at the discretion of the clinician and/or investigator, if they meet the above criteria.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are actively undergoing lung cancer treatment or have a history of lung&#xD;
             cancer, except for cases of completely resected pathologic stage IA nonsmall cell lung&#xD;
             cancer (NSCLC). Patients with stage IA NSCLC and multiple GGOs can enroll in this&#xD;
             active surveillance protocol after complete resection of the NSCLC and confirmation of&#xD;
             stage on final pathologic assessment.&#xD;
&#xD;
          -  The presence of any solid lesion ≥0.6 cm suspicious for malignancy.&#xD;
&#xD;
          -  Patients who are actively undergoing treatment for other malignancies&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James Huang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>James Huang, MD</last_name>
    <phone>212-639-2530</phone>
    <email>huangj@mskcc.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>David R Jones, MD</last_name>
    <phone>212-639-6428</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of California San Diego</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Mark Onaitis, MD</last_name>
      <phone>858-657-7000</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Stanford University Medical Center (Data collection only)</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305-5408</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Douglas Liou, MD</last_name>
      <phone>650-498-6000</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hartford Healthcare</name>
      <address>
        <city>Hartford</city>
        <state>Connecticut</state>
        <zip>06102</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tejal Shah, MD</last_name>
      <phone>860-827-2710</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Rush University Medical Center (Data collection only)</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>606012</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christopher Seder, MD</last_name>
      <phone>312-738-3732</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital Cancer Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michael Lanuti, MD</last_name>
      <phone>617-726-6751</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Brigham and Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Matthew Rochefort, MD</last_name>
      <phone>844-294-5864</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jules Lin, MD</last_name>
      <phone>734-936-8857</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shanda Blackman, MD,MPH</last_name>
      <phone>507-538-3270</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>George Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Benjamin S. Kozower, MD</last_name>
      <phone>314-362-8089</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Benjamin Kozower, MD</last_name>
      <phone>314-362-8089</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Basking Ridge</name>
      <address>
        <city>Basking Ridge</city>
        <state>New Jersey</state>
        <zip>07920</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>James Huang, MD</last_name>
      <phone>212-639-2530</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Monmouth</name>
      <address>
        <city>Middletown</city>
        <state>New Jersey</state>
        <zip>07748</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>James Huang, MD</last_name>
      <phone>212-639-2530</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Bergen</name>
      <address>
        <city>Montvale</city>
        <state>New Jersey</state>
        <zip>07645</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>James Huang, MD</last_name>
      <phone>212-639-2530</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Roswell Park Cancer Institute (Data Collection Only)</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14263-0001</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Commack</name>
      <address>
        <city>Commack</city>
        <state>New York</state>
        <zip>11725</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>James Huang, MD</last_name>
      <phone>212-639-2530</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Westchester</name>
      <address>
        <city>Harrison</city>
        <state>New York</state>
        <zip>10604</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>James Huang, MD</last_name>
      <phone>212-639-2530</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>James Huang, MD</last_name>
      <phone>212-639-2530</phone>
    </contact>
    <contact_backup>
      <last_name>David R. Jones, MD</last_name>
      <phone>212-639-6428</phone>
    </contact_backup>
    <investigator>
      <last_name>James Huang, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>New York Presbyterian Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nasser Altorki, MD</last_name>
      <phone>212-746-5156</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Nassau</name>
      <address>
        <city>Uniondale</city>
        <state>New York</state>
        <zip>11553</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>James Huang, MD</last_name>
      <phone>212-639-2530</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27701</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Betty Tong, MD</last_name>
      <phone>919-613-1909</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Lehigh Valley Health Network</name>
      <address>
        <city>Allentown</city>
        <state>Pennsylvania</state>
        <zip>18103</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>C. Gerard Petersen, MD</last_name>
      <phone>888-402-5846</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania (Data Collection Only)</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Doraid Jarrar, MD</last_name>
      <phone>215-662-9195</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Thomas Jefferson University Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nathaniel Evans III, MD</last_name>
      <email>nathaniel.evans@jefferson.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Fox Chase Cancer Center</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19111</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stacey Su, MD</last_name>
      <phone>888-369-2427</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Temple University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19140</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Cherie Erkmen, MD</last_name>
      <phone>215-707-9115</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Allegheny Health Network</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15212</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Benny Weksler, MD</last_name>
      <phone>412-359-6137</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh Medical Center</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Arjun Pennathur, MD</last_name>
      <phone>412-648-6271</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030-4009</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mara Antonoff, MD</last_name>
      <email>MBAntonoff@mdanderson.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Baylor University Medical Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Robert Taylor Ripley, MD</last_name>
      <phone>713-798-6376</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>McMaster University (Data Collection Only)</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8N 3Z5</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yaron Shargall, MD, BSc, FRCSC, FCCP</last_name>
      <phone>(905) 522-1155 x33229</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Health Network</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2C4</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Laura Donahoe, MD</last_name>
      <email>laura.donahoe@uhn.ca</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de l'Université de Montreal</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H2L 4M1</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Moishe Liberman, MD. PhD</last_name>
      <phone>514-890-8000, ext: 26832</phone>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mskcc.org/mskcc/html/44.cfm</url>
    <description>Memorial Sloan Kettering Cancer Center</description>
  </link>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>July 18, 2023</last_update_submitted>
  <last_update_submitted_qc>July 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 19, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_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_description>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03802981
org study id: 18-541
nct id: NCT03802981
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Cohort
time perspective: Prospective
measure: lung cancer-specific survival
time frame: 5 years
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: James Huang, MD
role: Principal Investigator
affiliation: Memorial Sloan Kettering Cancer Center
last name: James Huang, MD
phone: 212-639-2530
email: huangj@mskcc.org
last name: David R Jones, MD
phone: 212-639-6428
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Canada
country: United States
url: http://www.mskcc.org/mskcc/html/44.cfm
description: Memorial Sloan Kettering Cancer Center
responsible party type: Sponsor
sharing ipd: Yes
ipd 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 info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)