TuberculosisSCORE-TBNCT07485868
Development of a Clinical-epidemiological Score Predictive of Tuberculosis.
An observational study of Tuberculosis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial summary
Despite being a curable and preventable disease, tuberculosis still represents a major global health problem. It is estimated that 10.8 million people contracted tuberculosis in 2023, with an incidence of 134 per 100,000 inhabitants. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis
- What is being tested?
- Development and validation of a clinical-epidemiological predictive score for the diagnosis of pulmonary tuberculosis
- How many people
- 686 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 1 Apr 2030
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with clinically suspected tuberculosis Infectious disease specialists and emergency room physicians
Who may be able to join
- atients aged ≥18 years;
- Patients hospitalized during the study period who, due to a clinical suspicion of tuberculosis, underwent diagnostic tests on respiratory samples (sputum, induced sputum, tracheal aspirate, bronchoalveolar lavage) at the Fondazione Policlinico Universitario "A. Gemelli" IRCCS.
- Informed consent will be obtained for prospective patients, while for retrospective patients, reference will be made to Article 110-bis of the Privacy Code.
Who cannot join
- Patients <18 years of age;
- Patient already included (each patient will be included only once, regardless of the number of isolations).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Creation of a Cohort of Patients With Tuberculosis or Suspected Tuberculosis Admitted to a University Hospital in a Low-endemic Setting, Development of a Clinical-epidemiological Score Predictive of Tuberculosis, Optimization of the Diagnostic-therapeutic Pathway.
Despite being a curable and preventable disease, tuberculosis still represents a major global health problem. It is estimated that 10.8 million people contracted tuberculosis in 2023, with an incidence of 134 per 100,000 inhabitants. In 2023, there were 1.25 million deaths, confirming this disease as a leading cause of death and the leading cause of death from a single infectious agent. It is a disease that primarily affects adults in their most productive years, with significant repercussions on family budgets. The aim of this study is to identify and characterize the demographic, epidemiological, microbiological, clinical, and radiological variables of the tuberculosis population that has come to our hospital's attention, as an exemplary population in a low-endemic setting. This study also aims to develop a tuberculosis risk score aimed at early differentiation between patients requiring respiratory isolation and those with negligible tuberculosis risk, and to improve diagnostic accuracy.
- Conditions
- Tuberculosis
- Being tested
- Development and validation of a clinical-epidemiological predictive score for the diagnosis of pulmonary tuberculosis
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Development and validation of a clinical-epidemiological predictive score for the diagnosis of pulmonary tuberculosisOther
Development and validation of a clinical-epidemiological predictive score for the diagnosis of pulmonary tuberculosis. External validation through surveys on clinicians
What is being measured
The primary outcome is the main question the study is designed to answer.
construction of a logistic regression model
construction of a logistic regression model based on clinical and epidemiological variables significantly associated with pulmonary tuberculosis
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Apr 2030 (estimated)
- Study completion1 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- 686 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonella Cingolani, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07485868
- Sponsor's protocol ID
- 15560
- Acronym
- SCORE-TB
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creation of a Cohort of Patients With Tuberculosis or Suspected Tuberculosis Admitted to a University Hospital in a Low-endemic Setting, Development of a Clinical-epidemiological Score Predictive of Tuberculosis, Optimization of the Diagnostic-therapeutic Pathway.
- ClinicalTrials.gov ID
- NCT07485868
- Acronym / sponsor ID
- SCORE-TB / 15560
- Conditions
- Tuberculosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 686 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Apr 2030 (estimated)
- Study completion
- 1 Apr 2030 (estimated)
- First posted
- 20 Mar 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.
Despite being a curable and preventable disease, tuberculosis still represents a major global health problem. It is estimated that 10.8 million people contracted tuberculosis in 2023, with an incidence of 134 per 100,000 inhabitants. In 2023, there were 1.25 million deaths, confirming this disease as a leading cause of death and the leading cause of death from a single infectious agent. It is a disease that primarily affects adults in their most productive years, with significant repercussions on family budgets. The aim of this study is to identify and characterize the demographic, epidemiological, microbiological, clinical, and radiological variables of the tuberculosis population that has come to our hospital's attention, as an exemplary population in a low-endemic setting. This study also aims to develop a tuberculosis risk score aimed at early differentiation between patients requiring respiratory isolation and those with negligible tuberculosis risk, and to improve diagnostic accuracy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with clinically suspected tuberculosis Infectious disease specialists and emergency room physicians
Key inclusion criteria (3 listed)
- atients aged ≥18 years;
- Patients hospitalized during the study period who, due to a clinical suspicion of tuberculosis, underwent diagnostic tests on respiratory samples (sputum, induced sputum, tracheal aspirate, bronchoalveolar lavage) at the Fondazione Policlinico Universitario "A. Gemelli" IRCCS.
- Informed consent will be obtained for prospective patients, while for retrospective patients, reference will be made to Article 110-bis of the Privacy Code.
Key exclusion criteria (2 listed)
- Patients <18 years of age;
- Patient already included (each patient will be included only once, regardless of the number of isolations).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Development and validation of a clinical-epidemiological predictive score for the diagnosis of pulmonary tuberculosisDevelopment and validation of a clinical-epidemiological predictive score for the diagnosis of pulmonary tuberculosis. External validation through surveys on clinicians | Other | – |
Primary outcome
construction of a logistic regression model
Time frame: 5 years
construction of a logistic regression model based on clinical and epidemiological variables significantly associated with pulmonary tuberculosis
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 20 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Antonella Cingolani principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
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 2 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: opening soon, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Antonella Cingolani, Dr (00390630154945, antonella.cingolani@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
construction of a logistic regression model (time frame: 5 years). 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 20 Mar 2026.