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Exhaled Breath Electronic Nose for Multi-Disease Risk Prescreening

NCT07804017 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 20000

Last updated 2026-09-04

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • The First Affiliated Hospital of Guangzhou Medical University

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2028-01-01
Completion
2028-09-01

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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 NCT07804017 on ClinicalTrials.gov