An observational study in Lung Cancer, Pulmonary Nodule and Chronic Respiratory Disease, sponsored by The First Affiliated Hospital of Guangzhou Medical University. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by The First Affiliated Hospital of Guangzhou Medical University · Observational
Among 26 studies in Lung Neoplasms by The First Affiliated Hospital of Guangzhou Medical University — 20 open to participants now, 20 under way, none of them phase 3. Lung Neoplasms · The First Affiliated Hospital of Guangzhou Medical University.
Among the 26 studies in Lung Neoplasms by The First Affiliated Hospital of Guangzhou Medical University, this one is one of 4 that started in 2026, is one of 8 observational ones, reaches primary completion later than 15 of the 19 other live ones, and was the 25th registered.
5,422 studies on the registry are indexed under Lung Neoplasms; 1,346 are open to participants now.
This study's planned enrollment of 20,000 is above the median of 200 across 1,434 observational studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →20 of the 26 studies in Lung Neoplasms by The First Affiliated Hospital of Guangzhou Medical University are open now, in 1 country. Each count lists the studies.
Of the 996 Lung Neoplasms studies recruiting now, 683 (69%) set no upper age limit and 142 (14%) stop at 75 or younger; 45 take children under 18; 142 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →26 studies; the count open now beside each. This study's row is marked.
First in 2010; this study’s year is marked. 4 started in 2026.
Median enrollment 110 across the 18 interventional studies, 550 across the 8 observational. Of the 4 that completed or were terminated, 0 (0%) have results posted.
The First Affiliated Hospital of Guangzhou Medical University is the lead sponsor of 167 studies on the registry; 69 are open to participants now.
8 of the studies in Lung Neoplasms by The First Affiliated Hospital of Guangzhou Medical University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07170059The First Affiliated Hospital of Guangzhou Medical UniversityObservational Study on the Impact of Herpes Zoster Vaccine on the Incidence of Herpes Zoster and Survival in Lung Cancer Patients | 2026-11-01 |
| NCT07150416The First Affiliated Hospital of Guangzhou Medical UniversityNebulized Inhalation of Recombinant Human p53 Adenovirus Injection for Treatment of Multiple Ground-Glass Lung Nodules: A Single-Arm Clinical Study | 2026-12-01 |
| NCT06778512The First Affiliated Hospital of Guangzhou Medical UniversityLcProt: Proteomics Longitudinal Cohort Study on Lung Cancer | 2026-12-01 |
| NCT06422637The First Affiliated Hospital of Guangzhou Medical UniversityA Prospective Interventional Study on Early Screening for Lung Cancer Using Liquid Biopsy | 2026-12-01 |
| NCT06843707The First Affiliated Hospital of Guangzhou Medical UniversityEstablishing a Longitudinal Cohort Study of Lung Cancer Using Tissue and Peripheral Blood Metabolomics. | 2026-12-31 |
Among the 26 studies in Lung Neoplasms by The First Affiliated Hospital of Guangzhou Medical University, from their registry updates:
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.
This is an investigator-initiated, prospective, multicenter, observational, staged platform cohort study involving hospitals and health examination centers. The study is designed to establish a standardized and traceable exhaled-breath electronic-nose platform and to evaluate its potential role as a first-line risk prescreening tool rather than as a stand-alone diagnostic test. Up to 20,000 participants will be prospectively enrolled.
The first stage is a methodological standardization and cross-center consistency cohort of approximately 500 clinically stable participants. Each participant will complete three predefined breathing maneuvers in randomized order: end-expiratory sampling without breath holding, sampling after a 5-second breath hold, and sampling after a 10-second breath hold. Each maneuver will be repeated twice. At least 250 participants will undergo repeat sampling at 7±3 days and 30±7 days, and selected participants will undergo cross-device or cross-center bridge sampling. Repeatability, within-participant variability, sample validity, tolerability, and device/center consistency will be evaluated to determine the locked sampling and quality-control procedure for the subsequent large cohort.
The second stage is a multi-disease risk prescreening cohort of approximately 19,500 participants. Prespecified major disease modules include lung cancer/clinically significant pulmonary nodules, chronic respiratory diseases, and metabolic/endocrine diseases. Liver, kidney, cardiovascular, and systemic inflammatory/infectious/immune conditions will be evaluated as secondary or exploratory modules. Because participants may have more than one condition, disease outcomes will be modeled using a multi-label rather than mutually exclusive classification framework.
Approximately 12,000 participants will be used for model development, approximately 3,000 for temporally independent evaluation, and approximately 4,500 from prespecified held-out centers for whole-center external evaluation. Preprocessing procedures, model architecture, features, module-specific screening thresholds, and the overall screening rule will be locked before evaluation data are analyzed. Temporal and whole-center external evaluation datasets will not be used for model tuning or threshold selection.
Reference status for each disease module will be determined from routine clinical or health-screening information, including laboratory testing, pulmonary function testing, imaging, pathology, specialist assessment, and routine follow-up as applicable. The study will not require additional CT scans, blood sampling, endoscopy, surgery, or other invasive procedures solely to establish the reference standard. Participants with insufficient reference information will not be included in the corresponding primary accuracy analysis.
Primary evaluation of the locked risk prescreening models will include sensitivity, specificity, false-negative rate, and 95% confidence intervals at fixed thresholds. Positive predictive value, negative predictive value, and screening-positive rate will also be reported in consecutively recruited intended-use populations without case enrichment. Secondary analyses will assess AUROC, AUPRC, likelihood ratios, Brier score, calibration, decision-curve net benefit, subgroup performance, and transportability across centers, devices, and acquisition periods.
A nested longitudinal/repeat-sampling cohort of approximately 600-1,000 participants, with an upper limit of 3,000, may undergo repeat breath sampling at routine preoperative/postoperative, treatment, follow-up, or health examination visits to explore within-person temporal changes in breath profiles. These analyses are exploratory and are not part of the primary risk prescreening conclusions.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Age ≥18 years. Able to provide 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 , 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
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.
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.
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.
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.
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.
Adverse Event Rate During or Immediately After Exhaled-Breath Sampling
The adverse event rate will be defined as the proportion of participants experiencing one or more adverse events during or immediately after exhaled-breath sampling, including cough, dyspnea, chest tightness, dizziness, nausea, syncope, hypoxemia, or other adverse events recorded in association with the sampling procedure.
Time frame: During and immediately after each exhaled-breath sampling procedure.
No study locations are listed for this record.
Start is estimated for Sep 2026; primary completion for Jan 2028, 16 months later.
Of 591 non-industry observational studies under Lung Neoplasms, half reached primary completion within 65 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 162. This study's planned 16 months is below that.
Counting every sponsor, half of 681 studies reached it within 57 months; a quarter within 25 and three quarters within 135.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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The First Affiliated Hospital of Guangzhou Medical University →