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Completed

NCT Number: NCT03795181

Prediction Model for Multiple Pulmonary Nodules

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.

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Key information

Conditions

Multiple Pulmonary Nodules Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University People's Hospital

Beijing, 100044, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Performance of PKUM model

    Time frame: 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 outcomes

  1. Comparison between PKUM model and clinicians

    Time frame: 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

    Time frame: 3 months

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

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 7, 2019
Registry last updated
Aug 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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