Clincosm LogoSign in Get a demo

HRCT in Prediction of Tumor Invasion in GGO Lung Adenocarcinoma

Sponsor
Fudan University (Other)
Overall Status
Completed
CT.gov ID
NCT04165759
Collaborator
Fujian Medical University Union Hospital (Other), Shandong First Medical University Affiliated Liaocheng Second Hospital (Other), Jiangdu People's Hospital, Yangzhou (Other)
620
Enrollment
2
Locations
19.4
Actual Duration (Months)
310
Patients Per Site
16
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aims to evaluate the correlation between radiological diagnosis based on HRCT and pathological invasiveness.Investigators observe the radiological features and the correlation with the postoperative pathological findings.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Preoperative evaluation of pathologic tumor invasion of ground glass opacity (GGO) featured lung adenocarcinoma is important for selection of appropriate surgical extent. Whether thoracic high-resolution computed tomography (HRCT) scan could precisely predict pathologic tumor invasion remains unknown. Patients with peripheral GGO nodules (GGNs) would be enrolled, and HRCT with target scan would be performed preoperatively. Pathologic tumor invasion (invasive adenocarcinoma [IAD] versus adenocarcinoma in situ [AIS]/minimally invasive adenocarcinoma [MIA]) would be evaluated according to radiologic parameters of HRCT before surgery. Primary endpoint of this trial is the diagnostic sensitivity of pathologic tumor invasion evaluated by HRCT. Secondary endpoint is the diagnostic value of radiologic parameters of HRCT for pathologic tumor invasion of GGO featured lung adenocarcinoma.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    620 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Preoperative Evaluation of High-resolution Computed Tomography to Predict Pathologic Tumor Invasion in Ground-glass Opacity Featured Lung Adenocarcinoma
    Actual Study Start Date :
    Nov 18, 2019
    Actual Primary Completion Date :
    Apr 30, 2021
    Actual Study Completion Date :
    Jul 1, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    patients

    Patients with lung cancer who are candidates for surgery.

    Outcome Measures

    Primary Outcome Measures

    1. Sensitivity [Pathologic reports were available, usually 1 month after surgery]

      Diagnostic sensitivity of pathologic tumor invasion evaluated by HRCT

    Secondary Outcome Measures

    1. Value of radiologic parameters for tumor invasion [Pathologic reports were available, usually 1 month after surgery]

      The receiver operating characteristic curve (ROC curve) and the area under the ROC curve (AUC) of the invasion prediction model based on radiologic parameters.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    (1) GGNs on HRCT scan; (2) clinical stage IA; (3) simultaneously no more than three nodules; (5) Age ranging from 15 to 85 years.

    Exclusion Criteria:

    (1) pathologically confirmed non-adenocarcinoma; (2) patients who did not receive surgery.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fudan University Cancer Center Shanghai Shanghai China 200032
    2 Fudan University Shanghai Cancer Center Shanghai China

    Sponsors and Collaborators

    • Fudan University
    • Fujian Medical University Union Hospital
    • Shandong First Medical University Affiliated Liaocheng Second Hospital
    • Jiangdu People's Hospital, Yangzhou

    Investigators

    • Principal Investigator: Haiquan Chen, Fudan University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Haiquan Chen, Director of Department of thoracic surgery and multidisciplinary group of thoracic oncology, Fudan University
    ClinicalTrials.gov Identifier:
    NCT04165759
    Other Study ID Numbers:
    • PRSHRCT
    First Posted:
    Nov 18, 2019
    Last Update Posted:
    Nov 22, 2021
    Last Verified:
    Nov 1, 2021
    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
    Additional relevant MeSH terms:
    Adenocarcinoma
    Adenocarcinoma of Lung

    Study Results

    No Results Posted as of Nov 22, 2021