Pulmonary DiseasesPROMPTNCT07585214
Prospective Multicenter Screening for Thoracic Disease Via Radiography
An observational study of Pulmonary Diseases and Respiratory Disease, run by Chinese Academy of Sciences at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Diseases, Respiratory Disease, Esophageal Diseases
- How many people
- 300,000 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2026to 31 Dec 2029
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants who received radiography for thoracic disease screen.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Dazhou Central Hospital
Dazhou, Sichuan
Zeyu Zhang, +86 15510661612, zhangzeyu@fingerpass.net.cn
About this study
Official title: Thoracic Disease Screening Via Radiography: a Prospective Multicenter Study
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.
- Conditions
- Pulmonary Diseases, Respiratory Disease, Esophageal Diseases
- Keywords
- PROMPT, Thoracic, Screen, Radiography, Multicenter, Prospective
- Medical subject headings
- Lung Diseases, Respiration Disorders, Esophageal Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Through study completion, an average of 1 year.
Secondary outcomes (3)
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.
Measured: Through study completion, an average of 1 year.
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.
Measured: Through study completion, an average of 1 year.
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.
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start1 May 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zeyu Zhang, PHD, Chinese Academy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07585214
- Sponsor's protocol ID
- PROMPT
- Acronym
- PROMPT
- Status last verified
- May 2026
- First submitted
- 4 May 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoracic Disease Screening Via Radiography: a Prospective Multicenter Study
- ClinicalTrials.gov ID
- NCT07585214
- Acronym / sponsor ID
- PROMPT / PROMPT
- Conditions
- Pulmonary Diseases, Respiratory Disease, Esophageal Diseases
- Keywords
- PROMPT, Thoracic, Screen, Radiography, Multicenter, Prospective
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300,000 participants (estimated)
- Lead sponsor
- Chinese Academy of SciencesOther government
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 13 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who received radiography for thoracic disease screen.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
3 secondary outcomes
Diagnostic Performance Metrics
Time frame: Through study completion, an average of 1 year.
Multi-center Consistency and Inter-reader Reliability
Time frame: Through study completion, an average of 1 year.
Disease-Specific Detection Rates
Time frame: Through study completion, an average of 1 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Diseases and Respiratory Disease, run by Chinese Academy of Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zeyu Zhang, Ph.D. (+86 15510661612, zhangzeyu@fingerpass.net.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Detection Rate of Thoracic Diseases (time frame: Through study completion, an average of 1 year.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.