Breath Combined With CT for Diagnoses of Pulmonary Nodules
Assessment of the Efficacy of Breath Test Combined With Computed Tomography for Diagnoses of Pulmonary Nodules.
1 other identifier
observational
900
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2021
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 24, 2021
CompletedFirst Posted
Study publicly available on registry
July 1, 2021
CompletedStudy Start
First participant enrolled
July 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedApril 20, 2022
April 1, 2022
1.3 years
June 24, 2021
April 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Diagnostic sensitivity of breath test combined with computed tomography
Using pathological diagnosis of pulmonary nodule as gold standard, diagnostic specificity of breath test combined with computed tomography will be calculated
8 weeks
Diagnostic specificity of breath test combined with computed tomography
Using pathological diagnosis of pulmonary nodule as gold standard, diagnostic specificity of breath test combined with computed tomography will be calculated
8 weeks
Diagnostic accuracy of breath test combined with computed tomography
Using pathological diagnosis of pulmonary nodule as gold standard, diagnostic accuracy of breath test combined with computed tomography will be calculated
8 weeks
Secondary Outcomes (2)
Positive predictive value of breath test combined with computed tomography
8 weeks
Negative predictive value of breath test combined with computed tomography
8 weeks
Study Arms (2)
Malignant pulmonary nodules
Patients with pulmonary nodule diagnosed as malignant cancer by pathological examinations after surgical resection.
Benign pulmonary nodules
Patients with pulmonary nodule diagnosed as benign disease by pathological examinations after surgical resection.
Interventions
Pathological diagnosis, as the golden standard for diagnosing pulmonary nodules, is achieved by two experienced pathologists and validated by the third senior pathologist.
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.
Eligibility Criteria
To establish pulmonary nodule diagnosis model of breath test combined with computed tomography, we reviewed the prospective database established during the study of NCT04419207 for participant recruitment. 200 participants with malignant pulmonary nodules and 200 patients with benign pulmonary nodules will be included for establishing the diagnosis model. To validate the efficacy of the established model in distinguishing malignant pulmonary nodules from benign nodules, we will prospectively recruit 500 patients with pulmonary nodules in multi centers: Peking University People's Hospital (200 participants), The First Affiliated Hospital of Zhengzhou University (200 participants), and Beijing Haidian Hospital (100 participants).
You may qualify if:
- Age \> 18 years old;
- Pulmonary nodules with planned surgical resection;
- Signed informed consent and agreed to participate in this study.
You may not qualify if:
- Preoperative radiotherapy, chemotherapy, targeted therapy or other anti-tumor therapy
- The lack of chest computed tomography within two weeks before surgery
- A history of malignant disease within 5 years.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Peking University People's Hospitallead
- Beijing Haidian Hospitalcollaborator
- The First Affiliated Hospital of Zhengzhou Universitycollaborator
- Jiangsu Cancer Institute & Hospitalcollaborator
- Beijing Breatha Biological Technology Co., Ltd, Beijingcollaborator
Study Sites (1)
Peking University People's Hospital
Beijing, 100044, China
Biospecimen
Volatile organic compound (VOC) in exhalation collected with air bags.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mantang Qiu, PhD
Peking University People's Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Assistant
Study Record Dates
First Submitted
June 24, 2021
First Posted
July 1, 2021
Study Start
July 10, 2021
Primary Completion
October 30, 2022
Study Completion
December 31, 2022
Last Updated
April 20, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share