Prediction Model for Multiple Pulmonary Nodules

NCT ID: NCT03795181

Last Updated: 2019-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

59 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2019-03-30

Brief Summary

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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

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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.

Conditions

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Multiple Pulmonary Nodules

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jun Wang

Chief,Thoracic Surgery Service

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jun Wang

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Yuqing Huang

Role: STUDY_DIRECTOR

Haidian Section of Peking University Third Hospital

Jiabao Liu

Role: STUDY_DIRECTOR

People's Hospital Affiliated to Hebei Medical University

Yingtai Chen

Role: STUDY_DIRECTOR

Beijing Aerospace 711 Hospital

Mingru Li

Role: STUDY_DIRECTOR

Beijing Aerospace 731 Hospital

Locations

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Peking University People's Hospital

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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PTHO1902

Identifier Type: -

Identifier Source: org_study_id

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