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NCT Number: NCT07585214

Prospective Multicenter Screening for Thoracic Disease Via Radiography

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.

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Key information

Conditions

Pulmonary Diseases Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Lung Diseases Respiration Disorders Respiratory Disease Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Overall Detection Rate of Thoracic Diseases

    Time frame: 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.

  2. Screening Yield

    Time frame: 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 outcomes

  1. Diagnostic Performance Metrics

    Time frame: 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.

  2. Multi-center Consistency and Inter-reader Reliability

    Time frame: 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.

  3. Disease-Specific Detection Rates

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Zeyu Zhang, Ph.D.

CONTACT

[email protected]

+86 15510661612

Sponsors and collaborators

Lead sponsor

Chinese Academy of Sciences

Other Gov

Registry information

Official study title

Thoracic Disease Screening Via Radiography: a Prospective Multicenter Study

Acronym: PROMPT

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
May 13, 2026
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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