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NCT07804017

Exhaled Breath Electronic Nose for Multi-Disease Risk Prescreening

Sponsor: The First Affiliated Hospital of Guangzhou Medical University

View on ClinicalTrials.gov

Summary

This prospective multicenter observational study will evaluate whether an electronic nose that analyzes patterns in exhaled breath can be developed as a noninvasive tool for early risk prescreening across several disease areas. The study will enroll up to 20,000 adults from hospitals and health examination centers. It will first establish a standardized breath-sampling and quality-control procedure and assess repeatability across breathing maneuvers, devices, centers, and time. It will then develop and independently evaluate risk prescreening models for prespecified disease modules, including lung cancer/clinically significant pulmonary nodules, chronic respiratory diseases, and metabolic/endocrine diseases, with additional exploratory modules involving liver, kidney, cardiovascular, and systemic inflammatory/infectious/immune conditions. The electronic-nose results are for research only and will not be reported to participants or clinicians or used to change routine screening, diagnosis, or treatment. Disease reference status will be determined from examinations, laboratory tests, imaging, pathology, pulmonary function testing, specialist assessments, or follow-up that are already performed as part of routine care. The study will evaluate screening sensitivity, specificity, false-negative rate, predictive values, calibration, and performance across different centers, devices, and time periods.

Official title: Development and Validation of an Exhaled Breath Electronic Nose Platform for Multi-Disease Risk Prescreening: A Prospective Multicenter Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

20000

Start Date

2026-09-01

Completion Date

2028-09-01

Last Updated

2026-09-04

Healthy Volunteers

Yes

Interventions

DIAGNOSTIC_TEST

Electronic-Nose Breath Assessment

Participants will provide standardized exhaled-breath samples for electronic-nose analysis. The electronic-nose system records multichannel gas-sensor responses together with flow, temperature, humidity, and process information. In the methodological standardization cohort, participants will undergo repeated sampling using three predefined breathing maneuvers to assess repeatability and cross-center/device consistency. In the multi-disease risk prescreening cohort, participants will undergo the locked standardized sampling procedure for development and independent evaluation of disease risk prescreening models. Electronic-nose results are for research purposes only and will not be reported to participants or clinicians or used to alter routine screening, diagnosis, or treatment.