Exhaled Breath Electronic Nose for Multi-Disease Risk Prescreening
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe First Affiliated Hospital of Guangzhou Medical University
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
Adults aged ≥18 years will be prospectively recruited from participating hospitals and health examination centers. The study population will include individuals undergoing routine health examinations, opportunistic screening, or planned disease-specific screening or clinical evaluation. Clinically stable volunteers will be enrolled in the methodological standardization cohort, while the multi-disease risk prescreening cohort will include consecutively recruited intended-use populations with available routine reference screening or sufficient clinical information for reference-status determination. Patients with suspected or confirmed disease may also be included for model development or exploratory analyses but will not replace the intended-use population for locked external evaluation.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Electronic-Nose Breath Assessment
Diagnostic testParticipants 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.
Treatment groups
20,000 Participants
are divided into 2 treatment groupsGroup A: Methodological Standardization Cohort1 intervention
Group B: Multi-Disease Risk Prescreening Cohort1 intervention
Trial outcomes
Primary outcomes
1
Same-Day Repeatability of the Locked Exhaled-Breath Sampling Method
Same-day repeatability of electronic-nose measurements obtained using the locked exhaled-breath sampling method will be assessed using the intraclass correlation coefficient (ICC) with 95% confidence intervals based on repeated measurements collected from the same participant during the same visit.
Time frame
During the baseline sampling visit; repeated samples are collected approximately 3-5 minutes apart.2
Screening Performance of the Locked Multi-Disease Risk Prescreening Models
For each prespecified major disease module meeting the required event-number threshold, sensitivity, specificity, false-negative rate, and corresponding 95% confidence intervals will be estimated at the locked screening threshold. Positive predictive value, negative predictive value, and screening-positive rate will additionally be reported in consecutively recruited, non-enriched intended-use populations. Temporal and whole-center external evaluations will be reported separately.
Time frame
From index breath sampling to completion and adjudication of the corresponding routine reference screening or clinical assessment, up to 16 months after index breath sampling.Secondary outcomes
1
Area Under the Receiver Operating Characteristic Curve of the Locked Risk Prescreening Models
For each prespecified major disease module meeting the required event-number threshold, discrimination of the locked risk prescreening model will be assessed using the area under the receiver operating characteristic curve (AUROC) with 95% confidence intervals. Temporal and whole-center external evaluations will be reported separately.
Time frame
From index breath sampling to completion and adjudication of the corresponding routine reference screening or clinical assessment, up to 16 months after index breath sampling.2
Downstream Examination Burden of the Any-Major-Module-Positive Rule
The downstream examination burden of the prespecified "any major module positive" rule will be estimated as the number of participants per 1,000 individuals screened who would be referred for further disease-specific screening or clinical assessment under the locked rule.
Time frame
From index breath sampling to completion and adjudication of the corresponding routine reference screening or clinical assessment, up to 16 months after index breath sampling.3
Valid-Sample Rate of Standardized Exhaled-Breath Sampling
The valid-sample rate will be defined as the proportion of completed exhaled-breath sampling procedures that meet the prespecified locked quality-control criteria for a valid electronic-nose sample.
Time frame
During each exhaled-breath sampling visit.4
Short-Term Stability of the Locked Exhaled-Breath Sampling Method
Short-term stability of electronic-nose measurements obtained using the locked sampling method will be assessed using the intraclass correlation coefficient (ICC) with 95% confidence intervals across baseline and repeat measurements at 7±3 days and 30±7 days.
Time frame
From baseline sampling through the 30±7-day repeat-sampling visit.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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