Detecting Lung Cancer Based on Exhaled Breath

April 18, 2022 updated by: zhouzuli, Peking University People's Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

2236

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100044
        • Peking University People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Eligible inpatients will be recruited from Department of Thoracic Surgery, Peking University People's Hospital and Beijing Haidian Hospital.

For healthy controls, eligible participants will be recruited from those who receive planned annual physical examination at Aerospace 731 Hospital.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with Surbery
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.
Diagnostic test: Breath 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).
Healthy Controls
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.
Diagnostic test: Breath 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 year
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
2 year
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
2 year
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
2 year
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
2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Collaborators

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

Investigators

  • Study Chair: Mantang Qiu, M.D, Peking University People's Hospital Thoracic Surgery Department
  • Principal Investigator: Zuli Zhou, M.D, Peking University People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2019

Primary Completion (ACTUAL)

December 31, 2020

Study Completion (ACTUAL)

January 31, 2022

Study Registration Dates

First Submitted

June 4, 2020

First Submitted That Met QC Criteria

June 4, 2020

First Posted (ACTUAL)

June 5, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 20, 2022

Last Update Submitted That Met QC Criteria

April 18, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019PHB095-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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