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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University People's Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 4, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 5, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 20, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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