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Mid-infrared Laser Spectroscopic Breath Analysis Technology for Clinical Diagnosis of Lung Cancer

Mid-infrared Laser Spectroscopic Breath Analysis Technology for Clinical Diagnosis of Lung Cancer

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600128555
Enrollment
Unknown
Registered
2026-07-22
Start date
2024-02-26
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Lung cancer

Interventions

Gold Standard:According to the diagnostic workflow for lung cancer outlined in the Clinical Practice Guidelines for Lung Cancer Diagnosis and Treatment of the Chinese Medical Association (2020 Edition
Index test:QCL-based VOCs detection system (prototype), Mid-infrared cavity ring-down spectroscopy (CRDS), Formaldehyde, Isoprene, Acetone, Pathological diagnosis (gold standard), Gas chromatography-m

Sponsors

Cancer Hospital, Chinese Academy of Medical Sciences, Shenzhen Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: Age >=18 years, both sexes; Meet one of the following: lung cancer cohort, benign lung disease cohort, healthy controls;The subject or their authorized representative signs the informed consent form.

Exclusion criteria

Exclusion criteria: Comorbid other malignant tumors; severe hepatic or renal dysfunction, infectious diseases, or severe infections; major psychiatric disorders or significant cognitive impairment; inability to cooperate with the breath test; pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
Area Under the Receiver Operating Characteristic Curve (AUC);

Secondary

MeasureTime frame
Sensitivity;Specificity;Positive Predictive Value (PPV);Negative Predictive Value (NPV);Exhaled volatile organic compound (VOC) concentrations;Serum tumor markers (CEA, NSE, CYFRA21-1);

Countries

China

Contacts

Public ContactDuan Boshi

Cancer Hospital, Chinese Academy of Medical Sciences, Shenzhen Center

188214220@qq.com+86 138 4049 9941

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026