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Prediction Model for Multiple Pulmonary Nodules

Sponsor
Peking University People's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03795181
Collaborator
(none)
59
Enrollment
1
Location
2.9
Actual Duration (Months)
20.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study compares the sensitivity, specificity and accuracy of radiologists, thoracic surgeons and a predictive model (PKUM model) to discriminate malignancy from benign nodules in patients with multiple pulmonary nodules.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    It is clinically difficult to diagnose and manage patients with multiple pulmonary nodules (MPNs). We have developed a web-based mathematic model (PKUM model) by using a multi-centric database from three institutions (Peking University People's Hospital, Haidian Section of Peking University Third Hospital, People's Hospital Affiliated to Hebei Medical University) to predict the probability of a nodule to be malignant in patients with MPNs. This prospectively observational study will recruit patients with MPNs between January 2019 and March 2019, allowing radiologists, surgeons, and a predictive model (PKUM model) to discriminate malignancy from benign nodules, and compare their sensitivity, specificity, and accuracy.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    59 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prediction Model for Multiple Pulmonary Nodules
    Actual Study Start Date :
    Jan 1, 2019
    Actual Primary Completion Date :
    Mar 30, 2019
    Actual Study Completion Date :
    Mar 30, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Performance of PKUM model [3 months]

      Area under receiver operating characteristic curve (AUC) of PKUM model in predicting the probability of a nodule to be malignant in patients with multiple pulmonary nodules.

    Secondary Outcome Measures

    1. Comparison between PKUM model and clinicians [3 months]

      Comparison of sensitivity and specificity of radiologists, thoracic surgeons, and PKUM model in predicting the probability of a nodule to be malignant in patients with multiple pulmonary nodules.

    2. Performance of PKUM model in equivocal nodules which is difficult to judge by clinicians [3 months]

      Sensitivity and specificity of PKUM model in predicting malignant probability of equivocal nodules judged by radiologists and thoracic surgeons.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients with newly discovered, 4-30 mm multiple pulmonary nodules shown on thoracic CT scans

    • Patients with at least two nodules resected for pathological evaluation

    Exclusion Criteria:

    • History of malignancy within 5 years

    • Presence of pneumonia or pleural effusion on thoracic CT scans

    • Patients with none or only one nodule resected

    • Patients with initial chemo-radiation therapy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Peking University People's Hospital Beijing China 100044

    Sponsors and Collaborators

    • Peking University People's Hospital

    Investigators

    • Principal Investigator: Jun Wang, Peking University People's Hospital
    • Study Director: Yuqing Huang, Haidian Section of Peking University Third Hospital
    • Study Director: Jiabao Liu, People's Hospital Affiliated to Hebei Medical University
    • Study Director: Yingtai Chen, Beijing Aerospace 711 Hospital
    • Study Director: Mingru Li, Beijing Aerospace 731 Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jun Wang, Chief，Thoracic Surgery Service, Peking University People's Hospital
    ClinicalTrials.gov Identifier:
    NCT03795181
    Other Study ID Numbers:
    • PTHO1902
    First Posted:
    Jan 7, 2019
    Last Update Posted:
    Aug 28, 2019
    Last Verified:
    Aug 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jun Wang, Chief，Thoracic Surgery Service, Peking University People's Hospital
    multiple pulmonary nodules; predictive model
    Additional relevant MeSH terms:
    Multiple Pulmonary Nodules

    Study Results

    No Results Posted as of Aug 28, 2019