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RecruitingNCT07585214PROMPTUpdated May 13, 2026

Prospective Multicenter Screening for Thoracic Disease Via Radiography

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

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300,000
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Pulmonary Diseases
  • Respiratory Disease
  • Esophageal Diseases

Keywords

  • PROMPT
  • Thoracic
  • Screen
  • Radiography
  • Multicenter
  • Prospective
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Participants who received radiography for thoracic disease screen.

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

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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300,000 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes
05

What researchers measure

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.

06

Study locations

1 of 1 sites recruiting
07

Registry details

Key details

Study ID
NCT07585214
Lead sponsor
Chinese Academy of Sciences
Responsible party
Zeyu Zhang, PHD (Professor, Chinese Academy of Sciences) — Principal investigator
First posted
May 13, 2026
Start date
May 1, 2026 (estimated)
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
May 13, 2026

Study contacts

Zeyu Zhang, Ph.D.
Contact
zhangzeyu@fingerpass.net.cn
+86 15510661612

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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