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Clinical Trials/NCT04419207
NCT04419207
Completed
Not Applicable

Detecting Lung Cancer by Volatile Organic Compounds in Exhaled Breath: a Study of Lung Cancer Diagnostic Biomarker

Peking University People's Hospital1 site in 1 country2,236 target enrollmentMarch 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Carcinoma
Sponsor
Peking University People's Hospital
Enrollment
2236
Locations
1
Primary Endpoint
Positive predictive value of exhaled breath
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2019
End Date
January 31, 2022
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

zhouzuli

M.D.,Department of Thoracic Surgery

Peking University People's Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Positive predictive value of exhaled breath

Time Frame: 2 year

Using pathologic diagnosis of lung cancer as gold standard, positive predictive value of exhaled breath will be calculated

Negative predictive value of exhaled breath

Time Frame: 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

Time Frame: 2 year

Using pathologic diagnosis of lung cancer as gold standard, diagnostic sensitivity of exhaled breath will be calculated

Diagnostic accuracy of exhaled breath

Time Frame: 2 year

Using pathologic diagnosis of lung cancer as gold standard, diagnostic accuracy of exhaled breath will be calculated

Diagnostic specificity of exhaled breath

Time Frame: 2 year

Using pathologic diagnosis of lung cancer as gold standard, diagnostic specificity of exhaled breath will be calculated

Study Sites (1)

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