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A Real-world Study for Patients With Multiple Pulmonary Ground-glass Nodules

Sponsor
Tongji Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04192201
Collaborator
(none)
200
Enrollment
1
Location
60
Anticipated Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to actively monitor patients with multiple pulmonary Ground-glass Nodules (GGNs), in order to provide evidence for multiple GGNs treatment.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Multiple pulmonary GGNs are very commonly identified particularly as increasing numbers of CT scans are performed as part of routine lung cancer screening. At the same time, the ideal solution for these cases continues to be debated. This aim of this study is to learn more about the effects of multiple factors on outcome of multiple pulmonary GGNs, such as patients' clinical characteristics, CT features and different pathological types. Furthermore, the optimal timing of surgery and the effect of different surgical choices on the prognosis of patients with multiple GGNs will be investigated.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Real-world Study for Patients With Multiple Pulmonary Ground-glass Nodules
    Anticipated Study Start Date :
    Dec 31, 2019
    Anticipated Primary Completion Date :
    Dec 31, 2021
    Anticipated Study Completion Date :
    Dec 31, 2024

    Outcome Measures

    Primary Outcome Measures

    1. 5-year overall survival [Time Frame: From date of the recruitment, assessed up to 60 months] [October 31, 2024]

      5-year overall survival

    Secondary Outcome Measures

    1. 5-year Progression-Free-Survival [Time Frame: From date of the recruitment, assessed up to 60 months] [October 31, 2024]

      5-year Progression-Free-Survival

    2. Recurrence-free survival [Time Frame: From date of the recruitment, assessed up to 60 months] [October 31, 2024]

      Recurrence-free survival

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Age greater than 18 years

    2. Have two or more GGNs on CT imaging

    3. Diameter of GGNs > 5mm and ≤ 3cm

    4. GGNs must be greater than half ground glass

    Exclusion Criteria:

    1. patients who have a history of lung cancer

    2. patients who have undergone chemotherapy, radiotherapy or targeted therapy before surgery

    3. pregnant women

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tongji Hospital Wuhan Hubei China 430030

    Sponsors and Collaborators

    • Tongji Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tongji Hospital
    ClinicalTrials.gov Identifier:
    NCT04192201
    Other Study ID Numbers:
    • TJ-LC-02
    First Posted:
    Dec 10, 2019
    Last Update Posted:
    Dec 10, 2019
    Last Verified:
    Oct 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Tongji Hospital
    Multiple Pulmonary Nodules
    Lung Neoplasms
    Additional relevant MeSH terms:
    Multiple Pulmonary Nodules

    Study Results

    No Results Posted as of Dec 10, 2019