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Establishment of a Sensor Array-Based Screening System for Lung Cancer and Clinical Research

Establishment of a Sensor Array-Based Screening System for Lung Cancer and Clinical Research

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500106679
Enrollment
Unknown
Registered
2025-07-28
Start date
2023-09-05
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung cancer

Interventions

Sponsors

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion criteria for all study participants: 1. Age 18 years or older. 2. Patients suspected of having lung malignancies who are attending multiple centers, including the lead institution, Sir Run Run Shaw Hospital affiliated with Zhejiang University School of Medicine, or healthy individuals participating in health examinations. 3. Willingness to participate in this study and signing of informed consent. If the participant is unable to read the consent form (e.g., an illiterate participant), the consent process must be witnessed, and the consent signed by a witness. Inclusion criteria for participants in the pathologically negative control and pathologically positive experimental cohorts: 1. Chest CT scan shows lung nodules or masses, with clinical suspicion of malignancy, requiring hospital admission for further diagnosis. 2. After admission, participants undergo bronchoscopy biopsy, CT-guided lung puncture biopsy, or surgery to obtain a pathological diagnosis and have complete clinical information (including age, gender, height, weight, smoking history, COPD history, family history of cancer, clinical or pathological TNM stage of lung cancer, and presence of lung infections and comorbidities). 3. Willingness to cooperate with hospital follow-up after discharge. Inclusion criteria for participants in the blank control cohort: 1. Health examination participants. 2. Chest CT scan shows no lung lesions, and there is no clinical basis for a diagnosis of lung malignancy. 3. Complete clinical information (including age, gender, height, weight, smoking history, COPD history, family history of cancer, and presence of lung infections and comorbidities). 4. Willingness to cooperate with hospital follow-up.

Exclusion criteria

Exclusion criteria: Exclusion criteria: 1. Concurrent severe systemic diseases (including severe ischemic cardiomyopathy, malignant arrhythmias, uncontrollable epilepsy, advanced COPD, severe lung infections, other malignancies, etc.). 2. Lack of biopsy-confirmed pathology results or incomplete clinical data (the blank control group is assumed to be pathologically negative). 3. Inability to cooperate with breath sampling, preventing the collection of valid breath fingerprint samples. 4. Vulnerable groups, including individuals with mental illnesses, cognitive impairments, critically ill patients, minors, and pregnant women.

Design outcomes

Primary

MeasureTime frame
Breath fingerprint;

Countries

China

Contacts

Public ContactZhengfu He

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

hezhengfu@zju.edu.cn+86 138 6712 0566

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026