NCT04419207

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,236

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 4, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 5, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

April 20, 2022

Status Verified

April 1, 2022

Enrollment Period

1.8 years

First QC Date

June 4, 2020

Last Update Submit

April 18, 2022

Conditions

CarcinomaLung CancerNSCLCLung Neoplasms

Keywords

volatile organic compoundsexhaled breathbiomarker

Outcome Measures

Primary Outcomes (5)

  • Diagnostic sensitivity of exhaled breath

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

    2 year

  • Diagnostic specificity of exhaled breath

    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

    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

    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

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

    2 year

Study Arms (2)

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

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

Interventions

Breath testDIAGNOSTIC_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 ControlsPatients with Surbery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • pulmonary nodules in competed tomography images
  • plan to receive thoracic surgery
  • have planned physical examination every year
  • plan to receive low-dose computed tomography

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Exhaled breath samples will be collected with air bags.

MeSH Terms

Conditions

CarcinomaLung Neoplasms

Interventions

Breath Tests

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Mantang Qiu, M.D

    Peking University People's Hospital Thoracic Surgery Department

    STUDY CHAIR

  • Zuli Zhou, M.D

    Peking University People's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.，Department of Thoracic Surgery

Study Record Dates

First Submitted

June 4, 2020

First Posted

June 5, 2020

Study Start

March 1, 2019

Primary Completion

December 31, 2020

Study Completion

January 31, 2022

Last Updated

April 20, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)