Detecting Lung Cancer Based on Exhaled Breath

Completed

• Conditions: Lung Cancer; NSCLC; Lung Neoplasms; Carcinoma
• Interventions: Diagnostic Test: Breath test

• Registration Number: NCT04419207
• Lead Sponsor: Peking University People's Hospital

Brief Summary

Early detection is critical to improve the overall survival of lung cancer. Endogenous volatile organic compounds (VOCs) can be derived from many different metabolic pathways. On the other hand, cancer cells have different metabolism patterns compared with normal cells. Thus, detecting VOCs in exhaled breath using highly sensitive mass spectrometry would be a promising approach for lung cancer detection.

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.

In this study, we use a highly sensitive mass spectrometry to detect exhaled VOCs of lung cancer patients and healthy people. A lung cancer diagnosis model based on mass spectrometry data and support vector machine will be initially established and validated.

Study Timeline

• Study Start: 2019-03-01
• Study First Submitted: 2020-06-04
• Study First Submitted QC: 2020-06-04
• Study First Posted: 2020-06-05
• Primary Completion: 2020-12-31
• Study Completion: 2022-01-31
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-18
• Last Update Posted: 2022-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2236

Inclusion Criteria

Not provided

Exclusion Criteria

• history of malignant tumors.
• receive anti-tumor treatment such as radiotherapy, chemotherapy, targeted therapy before surgery
• with infections or liver disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Surbery	Breath test	Patients who with pulmonary nodules in computed tomography and planned to receive thoracic surgery will be included. And those who have other types of cancer, received anti-tumor treatment before surgery, liver disease, or infections will be excluded.
Healthy Controls	Breath test	Adult participants (\>18 yr) who plan to receive annual physical examination and low-dose computed tomography will be included. And those who have history cancers, received anti-tumor treatment before surgery, liver disease, or infections will be excluded.

Primary Outcome Measures

Name	Time	Method
Negative predictive value of exhaled breath	2 year	Using pathologic diagnosis of lung cancer as gold standard, negative predictive value of exhaled breath will be calculated
Diagnostic sensitivity of exhaled breath	2 year	Using pathologic diagnosis of lung cancer as gold standard, diagnostic sensitivity of exhaled breath will be calculated
Diagnostic accuracy of exhaled breath	2 year	Using pathologic diagnosis of lung cancer as gold standard, diagnostic accuracy of exhaled breath will be calculated
Diagnostic specificity of exhaled breath	2 year	Using pathologic diagnosis of lung cancer as gold standard, diagnostic specificity of exhaled breath will be calculated
Positive predictive value of exhaled breath	2 year	Using pathologic diagnosis of lung cancer as gold standard, positive predictive value of exhaled breath will be calculated

Trial Locations

Locations (1)

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