Prediction Model for Multiple Pulmonary Nodules

NCT03795181 | Completed

• 1 other identifier: PTHO1902
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Pulmonary Nodules

Keywords

multiple pulmonary nodules; predictive model

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Comparison between PKUM model and clinicians

  3 months

• Performance of PKUM model in equivocal nodules which is difficult to judge by clinicians

  3 months

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population include patients with multiple pulmonary nodules who will be diagnosed and treated between January 1，2019 and March 30, 2019. Patients with at least 2 nodules resected will be enrolled in this study.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, 100044, China

Location

MeSH Terms

Conditions

Multiple Pulmonary Nodules

Condition Hierarchy (Ancestors)

Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jun Wang

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

• 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 DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief，Thoracic Surgery Service

Study Record Dates

• First Submitted: January 1, 2019
• First Posted: January 7, 2019
• Study Start: January 1, 2019
• Primary Completion: March 30, 2019
• Study Completion: March 30, 2019
• Last Updated: August 28, 2019

Record last verified: 2019-08

Locations

CN (1)