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Breath Combined With CT for Diagnoses of Pulmonary Nodules

NCT04948047 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 900

Last updated 2022-04-20

No results posted yet for this study

Summary

Pulmonary nodules diagnosis using breath test of volatile organic compound (VOC) is in its infancy. The accuracy of VOC analysis in diagnosing malignant pulmonary nodules varies cross the published studies. The diagnosis accuracy of VOC alone is generally poor. We speculate that the accuracy of diagnosing malignant pulmonary nodules will be improved by combining breath test with chest computed tomography (CT). This study aims to establish a predictive model of malignant pulmonary nodule using bio-markers from exhaled breath and image-markers from chest CT with retrospective data from multi centers. The sensitivity, specificity and accuracy of the model will be validated prospectively.

Conditions

Interventions

DIAGNOSTIC_TEST

Pathological examinations as the golden diagnosis criteria

Pathological diagnosis, as the golden standard for diagnosing pulmonary nodules, is achieved by two experienced pathologists and validated by the third senior pathologist.

DIAGNOSTIC_TEST

Breath test combined with computed tomography

Exhaled breath of each participant will be collected with Tedlar bags. The volatile organic compounds will be detected by a high-resolution high-pressure photon ionization time-of-flight mass spectrometry (HPPI-TOFMS). The Imaging markers of pulmonary nodules, including the size, three-dimensional shape, and appearance characteristics, are derived from the chest computed tomography within 2 weeks before surgery resection.

Sponsors & Collaborators

  • Beijing Haidian Hospital

    collaborator OTHER

  • The First Affiliated Hospital of Zhengzhou University

    collaborator OTHER

  • Jiangsu Cancer Institute & Hospital

    collaborator OTHER

  • Beijing Breatha Biological Technology Co., Ltd, Beijing

    collaborator UNKNOWN

  • Peking University People's Hospital

    lead OTHER

Principal Investigators

  • Mantang Qiu, PhD · Peking University People's Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-10
Primary Completion
2022-10-30
Completion
2022-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04948047 on ClinicalTrials.gov