Prediction Model for Multiple Pulmonary Nodules

Multiple Pulmonary Nodules Clinical Trial

Official title:

Prediction Model for Multiple Pulmonary Nodules

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03795181
• Other study ID #: PTHO1902
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: March 30, 2019

Study information

• Verified date: August 2019
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: March 30, 2019
• Est. primary completion date: March 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Pulmonary Nodules

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance of PKUM model	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.	3 months
Secondary	Comparison between PKUM model and clinicians	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.	3 months
Secondary	Performance of PKUM model in equivocal nodules which is difficult to judge by clinicians	Sensitivity and specificity of PKUM model in predicting malignant probability of equivocal nodules judged by radiologists and thoracic surgeons.	3 months