Exhaled Breath Electronic Nose for Multi-Disease Risk Prescreening

NCT07804017 | Not Yet Recruiting

• 1 other identifier: BREATH-PAN-01
• Study Type: observational
• Target: 20,000
• Locations: 0 countries
• Sites: N/A

Brief 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

Lung Cancer; Pulmonary Nodule; Chronic Respiratory Disease; Metabolic Disease; Endocrine Disease

Keywords

Electronic Nose; Exhaled Breath; Multi-Disease Risk Prescreening; Artificial Intelligence; Machine Learning; Noninvasive Screening

Outcome Measures

Primary Outcomes (2)

• 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.

  During the baseline sampling visit; repeated samples are collected approximately 3-5 minutes apart.

• 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.

  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 (5)

• Area Under the Receiver Operating Characteristic Curve of the Locked Risk Prescreening Models

  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.

• Downstream Examination Burden of the Any-Major-Module-Positive Rule

  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.

• Valid-Sample Rate of Standardized Exhaled-Breath Sampling

  During each exhaled-breath sampling visit.

• Short-Term Stability of the Locked Exhaled-Breath Sampling Method

  From baseline sampling through the 30±7-day repeat-sampling visit.

• Adverse Event Rate During or Immediately After Exhaled-Breath Sampling

  During and immediately after each exhaled-breath sampling procedure.

Study Arms (2)

Methodological Standardization Cohort

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.

Diagnostic Test: Electronic-Nose Breath Assessment

Multi-Disease Risk Prescreening Cohort

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.

Diagnostic Test: Electronic-Nose Breath Assessment

Interventions

Electronic-Nose Breath Assessment DIAGNOSTIC_TEST

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.

Methodological Standardization Cohort; Multi-Disease Risk Prescreening Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Guangzhou Medical University: lead

MeSH Terms

Conditions

Lung Neoplasms; Metabolic Diseases; Endocrine System Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: August 15, 2026
• First Posted: September 4, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: September 4, 2026

Record last verified: 2026-08