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Exhaled Breath Electronic Nose for Multi-Disease Risk Prescreening

Not Yet RecruitingN/A

Sponsor: The First Affiliated Hospital of Guangzhou Medical University

Conditions: Lung Cancer, Pulmonary Nodule, Chronic Respiratory Disease, Metabolic Disease, Endocrine Disease

Interventions: Electronic-Nose Breath Assessment

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: Yes

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

Age ≥18 years. Able to provide informed consent and willing to sign written informed consent. Able to understand and follow standardized breathing instructions and safely complete seated exhaled-breath sampling.

Breath sampling is considered by the study physician not to delay or interfere with necessary routine clinical care or health examination.

Routine reference screening results are available for at least one prespecified disease module, or sufficient clinical information is available to determine the corresponding reference status.

Willing to permit authorized study personnel to review relevant medical records and follow-up information within the scope of ethical approval.

Exclusion Criteria:

Refusal to participate, inability to provide valid informed consent, or inability to reliably comply with study procedures.

Acute respiratory distress, active massive hemoptysis, untreated pneumothorax, significant impairment of consciousness, or any condition for which forced exhalation is considered unsafe by the study physician.

Requirement for strict airborne isolation when the study site or equipment cannot meet applicable infection-control requirements.

Recent major surgery, invasive procedure, or other clinical intervention for which the treating physician considers breath sampling should be postponed.

Vomiting, severe nausea, intense coughing, or other conditions before sampling that substantially increase the risk of aspiration, syncope, or related adverse events.

Acute oral or nasopharyngeal conditions, or recent food intake, smoking, alcohol consumption, vigorous exercise, or other factors that prevent standardized breath sampling; such participants may be rescheduled rather than permanently excluded.

Key reference-standard information is unavailable and is not expected to be obtained through routine follow-up.

Any other condition considered by the investigator to make participation inappropriate.