Breath Combined With CT for Diagnoses of Pulmonary Nodules

• Conditions: Non-small Cell Lung Cancer; Pulmonary Nodule, Multiple
• Interventions: Diagnostic Test: Pathological examinations as the golden diagnosis criteria; Diagnostic Test: Breath test combined with computed tomography

• Registration Number: NCT04948047
• Lead Sponsor: Peking University People's Hospital

Brief Summary

Pulmonary nodules diagnosis using breath test of volatile organic compound (VOC) is in its infancy. The accuracy of VOC analysis in diagnosing malignant pulmonary nodules varies cross the published studies. The diagnosis accuracy of VOC alone is generally poor. We speculate that the accuracy of diagnosing malignant pulmonary nodules will be improved by combining breath test with chest computed tomography (CT). This study aims to establish a predictive model of malignant pulmonary nodule using bio-markers from exhaled breath and image-markers from chest CT with retrospective data from multi centers. The sensitivity, specificity and accuracy of the model will be validated prospectively.

Detailed Description

Endogenous volatile organic compounds (VOCs) can be derived from many different metabolic pathways. VOCs can be transported to the alveoli through the blood circulation and expelled by exhalation. Changes in VOCs production, clearance, and alterations in lung air-blood exchange functions can lead to aberrant VOCs profiles in the exhaled breath. Testing exhaled breath has the advantages of being completely non-invasive and easy to collect, and has been considered as a perfect approach for disease diagnoses and therapeutic monitoring. Many clinical studies have found that VOCs in exhaled breath are closely related to disease status. Specific VOCs alterations have been identified in many tumors, especially lung cancer. Pulmonary nodules diagnosis using breath test of volatile organic compound (VOC) is in its infancy. The accuracy of VOC analysis in diagnosing malignant pulmonary nodules varies cross the published studies. The diagnosis accuracy of VOC alone is generally poor. We speculate that the accuracy of diagnosing malignant pulmonary nodules will be improved by combining VOC analysis with chest computed tomography.

In this study, we use a highly sensitive mass spectrometry to detect exhaled VOCs of patients with pulmonary nodules. The chest CT will be used for detecting the imaging characteristics of pulmonary nodules. The pathological diagnosis of pulmonary nodules after surgical resections is selected as golden standard.

This study aims to establish a predictive model of malignant pulmonary nodule using bio-markers from breath test and image-markers from chest CT with retrospective data from multi centers. The sensitivity, specificity and accuracy of the model will be varied prospectively.

Study Timeline

• Study First Submitted: 2021-06-24
• Study First Submitted QC: 2021-06-24
• Study First Posted: 2021-07-01
• Study Start: 2021-07-10
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-18
• Last Update Posted: 2022-04-20
• Primary Completion: 2022-10-30
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

1. Age > 18 years old;
2. Pulmonary nodules with planned surgical resection;
3. Signed informed consent and agreed to participate in this study.

Exclusion Criteria

1. Preoperative radiotherapy, chemotherapy, targeted therapy or other anti-tumor therapy
2. The lack of chest computed tomography within two weeks before surgery
3. A history of malignant disease within 5 years.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Malignant pulmonary nodules	Pathological examinations as the golden diagnosis criteria	Patients with pulmonary nodule diagnosed as malignant cancer by pathological examinations after surgical resection.
Benign pulmonary nodules	Pathological examinations as the golden diagnosis criteria	Patients with pulmonary nodule diagnosed as benign disease by pathological examinations after surgical resection.
Benign pulmonary nodules	Breath test combined with computed tomography	Patients with pulmonary nodule diagnosed as benign disease by pathological examinations after surgical resection.
Malignant pulmonary nodules	Breath test combined with computed tomography	Patients with pulmonary nodule diagnosed as malignant cancer by pathological examinations after surgical resection.

Primary Outcome Measures

Name	Time	Method
Diagnostic sensitivity of breath test combined with computed tomography	8 weeks	Using pathological diagnosis of pulmonary nodule as gold standard, diagnostic specificity of breath test combined with computed tomography will be calculated
Diagnostic specificity of breath test combined with computed tomography	8 weeks	Using pathological diagnosis of pulmonary nodule as gold standard, diagnostic specificity of breath test combined with computed tomography will be calculated
Diagnostic accuracy of breath test combined with computed tomography	8 weeks	Using pathological diagnosis of pulmonary nodule as gold standard, diagnostic accuracy of breath test combined with computed tomography will be calculated

Secondary Outcome Measures

Name	Time	Method
Negative predictive value of breath test combined with computed tomography	8 weeks	Using pathological diagnosis of pulmonary nodule as gold standard, negative predictive value of breath test combined with computed tomography will be calculated
Positive predictive value of breath test combined with computed tomography	8 weeks	Using pathological diagnosis of pulmonary nodule as gold standard, positive predictive value of breath test combined with computed tomography will be calculated

Trial Locations

Locations (1)

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