Prediction Model for Multiple Pulmonary Nodules

Completed

• Conditions: Multiple Pulmonary Nodules

• Registration Number: NCT03795181
• Lead Sponsor: Peking University People's Hospital

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.

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 Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2019-01-01
• Study First Submitted QC: 2019-01-03
• Study First Posted: 2019-01-07
• Primary Completion: 2019-03-30
• Study Completion: 2019-03-30
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-26
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, China