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NCT Number: NCT04419207

Detecting Lung Cancer Based on Exhaled Breath

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.

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Key information

Conditions

Carcinoma Lung Cancer Lung Diseases Lung Neoplasms NSCLC Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for inpatient :

  • pulmonary nodules in competed tomography images
  • plan to receive thoracic surgery

Inclusion criteria

for controls :

  • have planned physical examination every year
  • plan to receive low-dose computed tomography

Exclusion criteria

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

Treatment and study plan

Breath test

Diagnostic Test

Exhaled breath of each participant will be collected with air bags and directly detected by a high-resolution high-pressure photon ionization time-of-flight mass spectrometry (HPPI-TOFMS).

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Collaborators

  • Aerospace 731 Hospital
  • Beijing Breatha Biological Technology Co., Ltd, Beijing
  • Beijing Haidian Hospital
  • Jiangsu Cancer Institute & Hospital
  • The First Affiliated Hospital of Zhengzhou University

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2022
First posted
Jun 5, 2020
Registry last updated
Apr 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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