Esophageal Diseases, Pulmonary Diseases, Respiratory Disease
Conditions
Keywords
PROMPT, Thoracic, Screen, Radiography, Multicenter, Prospective
Brief summary
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.
Interventions
None listed
Sponsors
Chinese Academy of Sciences
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age over 18. * Ability to understand and willingness to sign a written informed consent form. * Individuals presenting for routine health examinations or community-based screening.
Exclusion criteria
* Women who are pregnant, lactating, or planning to become pregnant during the study period. * Physical limitations preventing stable positioning or breath-holding, or presence of metallic implants that may significantly degrade image quality. * Known history of advanced thoracic diseases currently under treatment (e.g., active lung cancer, end-stage pulmonary fibrosis, or congestive heart failure). * Individuals who have undergone chest CT or X-ray examinations within the past 3 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Detection Rate of Thoracic Diseases | Through study completion, an average of 1 year. | 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. |
| Screening Yield | Through study completion, an average of 1 year. | Defined as the number of newly identified, clinically significant thoracic disease cases detected per 1,000 screening examinations. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Performance Metrics | Through study completion, an average of 1 year. | 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. |
| Multi-center Consistency and Inter-reader Reliability | Through study completion, an average of 1 year. | 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. |
| Disease-Specific Detection Rates | Through study completion, an average of 1 year. | Stratified detection rates for specific thoracic abnormalities, including but not limited to pulmonary nodules (lung nodules), pneumonia, pneumothorax, cardiomegaly, and pleural effusion. |
Countries
China
Contacts
CONTACTZeyu Zhang, Ph.D.
Outcome results
None listed