Evaluation of Correlations Between Radiologic Features and Pathologic Subtypes of GGO LUAD Via WMS

Sponsor
Fudan University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05252676
Collaborator
(none)
100
1
11
9.1

Study Details

Study Description

Brief Summary

This study aims to evaluate the correlations between radiologic features and pathologic subtypes of ground glass opacity featured lung adenocarcinoma via whole-mount section.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The pathological lepidic growth pattern was believed to relate to the ground-glass component, whereas invasive adenocarcinoma patterns relate to the solid component. However, the solid components might be fibrosis rather tumor; and previous studies demonstrated the ground-glass components might be invasive lesions. Therefore, it is of considerable significance to establish the correlations between radiologic features and pathologic subtypes of ground glass opacity featured lung adenocarcinoma.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of Correlations Between Radiologic Features and Pathologic Subtypes of Ground Glass Opacity Featured Lung Adenocarcinoma Via Whole-Mount Section
    Actual Study Start Date :
    Jun 1, 2021
    Anticipated Primary Completion Date :
    Mar 1, 2022
    Anticipated Study Completion Date :
    May 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Patients

    Patients with ground glass opacity featured lung adenocarcinoma who are candidates for surgery.

    Outcome Measures

    Primary Outcome Measures

    1. Evaluation of correlations between radiologic features and pathologic subtypes [about 14 days]

      Evaluation of correlations between radiologic features and pathologic subtypes of ground glass opacity featured lung adenocarcinoma

    Secondary Outcome Measures

    1. Specificity, Sensitivity, and Repeatability [about 14 days]

      The specificity, sensitivity, and repeatability of invasiveness diagnosis based on the Whole-Mount Section

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Ground glass opacity featured lung nodule diagnosed by thin-section computed tomography(TSCT)

    • Pre-operation clinical IA stage

    • Pulmonary lobectomy or segmentectomy

    • Provision of informed consent

    Exclusion Criteria:
    • Postoperative diagnosis of non-adenocarcinoma or mucinous adenocarcinoma

    • The surgical specimens fail to satisfy requirement of inflation and formalin fixation

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • Fudan University

    Investigators

    • Principal Investigator: Haiquan Chen, M.D., Fudan University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Haiquan Chen, Professor, Fudan University
    ClinicalTrials.gov Identifier:
    NCT05252676
    Other Study ID Numbers:
    • IRB2106237-23
    First Posted:
    Feb 23, 2022
    Last Update Posted:
    Feb 23, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Haiquan Chen, Professor, Fudan University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 23, 2022