Prospective Multicenter Screening for Thoracic Disease Via Radiography
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChinese Academy of Sciences
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Participants who received radiography for thoracic disease screen.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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.2
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.Secondary outcomes
1
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.2
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.3
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov