Clinical trial · Observational
Exhaled Breath Electronic Nose for Multi-Disease Risk Prescreening
Development and Validation of an Exhaled Breath Electronic Nose Platform for Multi-Disease Risk Prescreening: A Prospective Multicenter Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Respiratory Disease | — | UNRESOLVED | — |
| Endocrine Disease | — | UNRESOLVED | — |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Metabolic Disease | — | UNRESOLVED | — |
| Pulmonary Nodule | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Electronic-Nose Breath Assessment | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Methodological Standardization Cohort
- description
- Approximately 500 clinically stable participants will undergo standardized exhaled-breath sampling to evaluate methodological repeatability and cross-center/device consistency. Participants will complete three predefined breathing maneuvers in randomized order, with each maneuver repeated twice. At least 250 participants will undergo repeat sampling at 7±3 days and 30±7 days, and selected participants may undergo cross-device or cross-center bridge sampling.
- interventionNames
- Diagnostic Test: Electronic-Nose Breath Assessment
- label
- Multi-Disease Risk Prescreening Cohort
- description
- Approximately 19,500 participants will undergo standardized exhaled-breath electronic-nose assessment before the corresponding routine reference screening results are available. The cohort will be used to develop and independently evaluate multi-label risk prescreening models for prespecified disease modules, including lung cancer/clinically significant pulmonary nodules, chronic respiratory diseases, and metabolic/endocrine diseases, with additional secondary or exploratory disease modules.
- interventionNames
- Diagnostic Test: Electronic-Nose Breath Assessment
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available