NCT07585214

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300,000

participants targeted

Target at P75+ for all trials

Timeline
44mo left

Started May 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
May 2026Dec 2029

Study Start

First participant enrolled

May 1, 2026

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 4, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 13, 2026

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

May 13, 2026

Status Verified

May 1, 2026

Enrollment Period

2.7 years

First QC Date

May 4, 2026

Last Update Submit

May 9, 2026

Conditions

Keywords

PROMPTThoracicScreenRadiographyMulticenterProspective

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Through study completion, an average of 1 year.

Secondary Outcomes (3)

  • Diagnostic Performance Metrics

    Through study completion, an average of 1 year.

  • Multi-center Consistency and Inter-reader Reliability

    Through study completion, an average of 1 year.

  • Disease-Specific Detection Rates

    Through study completion, an average of 1 year.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants who received radiography for thoracic disease screen.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dazhou Central Hospital

Dazhou, Sichuan, China

RECRUITING

MeSH Terms

Conditions

Lung DiseasesRespiration DisordersEsophageal Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesGastrointestinal DiseasesDigestive System Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 4, 2026

First Posted

May 13, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2029

Last Updated

May 13, 2026

Record last verified: 2026-05

Locations