Detecting Lung Cancer Based on Exhaled Breath

NCT ID: NCT04419207

Last Updated: 2022-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2236 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-01

Study Completion Date

2022-01-31

Brief Summary

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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

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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.

Conditions

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Carcinoma Lung Cancer NSCLC Lung Neoplasms

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Breath test

Intervention Type 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).

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.

Breath test

Intervention Type 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).

Interventions

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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).

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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


* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Haidian Hospital

OTHER

Sponsor Role collaborator

Aerospace 731 Hospital

OTHER

Sponsor Role collaborator

Beijing Breatha Biological Technology Co., Ltd, Beijing

UNKNOWN

Sponsor Role collaborator

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role collaborator

Jiangsu Cancer Institute & Hospital

OTHER

Sponsor Role collaborator

Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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zhouzuli

M.D.,Department of Thoracic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mantang Qiu, M.D

Role: STUDY_CHAIR

Peking University People's Hospital Thoracic Surgery Department

Zuli Zhou, M.D

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Locations

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Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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2019PHB095-01

Identifier Type: -

Identifier Source: org_study_id

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