An observational study in Pulmonary Diseases, Respiratory Disease and Esophageal Diseases, sponsored by Chinese Academy of Sciences. Recruiting at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-13.
Sponsored by Chinese Academy of Sciences · Observational
This multicenter, prospective study aims to evaluate the real-world clinical utility of chest X-ray (CXR) for large-scale thoracic disease screening. Adult participants presenting for health examinations will undergo digital CXR screening, and any suspected abnormalities will be confirmed via a gold standard reference, such as a chest CT scan or clinical follow-up. The primary outcome measure is the detection rate (screening yield) of confirmed thoracic conditions. Secondary measures will assess diagnostic accuracy (sensitivity and specificity), false-positive rates, and multi-center reading consistency. By providing prospective, large-cohort evidence, this research seeks to validate the cost-effectiveness and feasibility of CXR in identifying early-stage lung, pleural, and cardiac abnormalities, ultimately guiding public health strategies and optimizing early medical intervention.
Participants who received radiography for thoracic disease screen.
Exclusion Criteria:
Overall Detection Rate of Thoracic Diseases
Defined as the proportion of subjects with positive X-ray findings that are subsequently confirmed by a gold standard reference (e.g., CT scan, pathology, or comprehensive clinical follow-up) out of the total screened population.
Time frame: Through study completion, an average of 1 year.
Screening Yield
Defined as the number of newly identified, clinically significant thoracic disease cases detected per 1,000 screening examinations.
Time frame: Through study completion, an average of 1 year.
Diagnostic Performance Metrics
Evaluating the diagnostic accuracy of chest X-rays using CT as the gold standard. Metrics include: Sensitivity and Specificity, Positive Predictive Value (PPV) and Negative Predictive Value (NPV), Miss Rate (False Negative Rate), with a specific focus on early-stage lung nodules and occult pneumonia.
Time frame: Through study completion, an average of 1 year.
Multi-center Consistency and Inter-reader Reliability
Assessed using agreement coefficients (e.g., Cohen's Kappa or Intraclass Correlation Coefficient \[ICC\]) among radiologists with varying levels of experience across different participating centers when interpreting the radiographs.
Time frame: Through study completion, an average of 1 year.
Disease-Specific Detection Rates
Stratified detection rates for specific thoracic abnormalities, including but not limited to pulmonary nodules (lung nodules), pneumonia, pneumothorax, cardiomegaly, and pleural effusion.
Time frame: Through study completion, an average of 1 year.
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Chinese Academy of Sciences