Pneumocystis Jirovecii PneumoniaNCT05701631
Radiomics Model for the Diagnosis of Pneumocystis Jirovecii Pneumonia in Non-HIV Patients
An observational study of Pneumocystis Jirovecii Pneumonia, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
To evaluate the performance of radiomics in differentiating Pneumocystis jirovecii pneumonia (PCP) from other types of pneumonia and to improve the diagnostic efficacy of non-invasive tests in non-HIV patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumocystis Jirovecii Pneumonia
- What is being tested?
- Radiomic model
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2023to 30 Jun 2023
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 admitted to our institute with clinical suspected PCP
Who may be able to join
- aged over eighteen years;
- presence of an underlying disease known to be associated with PCP
- symptoms of lower respiratory tract infection, such as fever, cough or dyspnea
- signs of lung infection on high resolution CT at the on-set of the disease
- received BAL examination within three days after CT scans
- underwent qPCR and IF staining tests on the BAL fluid sample.
Who cannot join
- with HIV infection
- taking trimethoprim-sulfamethoxazole for prophylaxis
- undiagnosed by qPCR and IF staining tests
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the performance of radiomics in differentiating Pneumocystis jirovecii pneumonia (PCP) from other types of pneumonia and to improve the diagnostic efficacy of non-invasive tests in non-HIV patients.
Read the detailed description
Retrospective study, including non-HIV patients hospitalized for suspected PCP from January 2010 to December 2022. The included patients were randomized in a 7:3 ratio into training and validation cohorts. Radiomic features were extracted from semi-automatically identified infected areas in computed tomography (CT) scans and used to construct a radiomic model, which was then compared to a clinical-imaging model built with clinical and semantic CT features in terms of diagnostic performance of PCP. The combination of the radiomic model and serum β-D-glucan levels was also evaluated for PCP diagnosis.
- Conditions
- Pneumocystis Jirovecii Pneumonia
- Being tested
- Radiomic model
- Keywords
- Computed tomography, Diagnostic tests, Pneumocystis jirovecii pneumonia, Radiomics
- Medical subject headings
- Pneumonia, Pneumocystis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiomic modelDiagnostic test
Radiomic model for PCP diagnosis
| Study group | Role | What they receive |
|---|---|---|
| non-HIV patients hospitalized for suspected PCP | non-HIV patients hospitalized for suspected PCP Receives: Diagnostic Test: Radiomic model |
What is being measured
The primary outcome is the main question the study is designed to answer.
the diagnostic performance of radiomic model in the PCP diagnosis
The included patients were randomized in a 7:3 ratio into training and validation cohorts. Radiomic features were extracted from semi-automatically identified infected areas in computed tomography (CT) scans and used to construct a radiomic model. Then, the area under the curve (AUC) of the receiver operating characteristic (ROC) curves were calculated and used to evaluate the diagnostic performance (accuracy, sensitivity, specialty, positive predictive value, negative predictive value) of the model for PCP diagnosis in both training and validation cohorts.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start15 Jan 2023
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pneumocystis Jirovecii PneumoniaStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe 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
- Other
- Time perspective
- Other
- Enrolment
- 140 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Liang_An, Chinese PLA General Hospital
- Investigators
- Liang-an Chen, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05701631
- Sponsor's protocol ID
- S2023-006-01
- Status last verified
- Jan 2023
- First submitted
- 17 Jan 2023
- Last updated
- 27 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Contact the researcher for requests.
Publications
Yu H, Yang Z, Wei Y, Shi W, Zhu M, Liu L, Wang M, Wang Y, Zhu Q, Liang Z, Zhao W, Chen LA. Computed tomography-based radiomics improves non-invasive diagnosis of Pneumocystis jirovecii pneumonia in non-HIV patients: a retrospective study. BMC Pulm Med. 2024 Jan 2;24(1):11. doi: 10.1186/s12890-023-02827-4.
PubMed 38167022
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiomics Model for the Diagnosis of Pneumocystis Jirovecii Pneumonia in Non-HIV Patients
- ClinicalTrials.gov ID
- NCT05701631
- Acronym / sponsor ID
- S2023-006-01
- Conditions
- Pneumocystis Jirovecii Pneumonia
- Keywords
- Computed tomography, Diagnostic tests, Pneumocystis jirovecii pneumonia, Radiomics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 27 Jan 2023 (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.
To evaluate the performance of radiomics in differentiating Pneumocystis jirovecii pneumonia (PCP) from other types of pneumonia and to improve the diagnostic efficacy of non-invasive tests in non-HIV patients.
Detailed description
Retrospective study, including non-HIV patients hospitalized for suspected PCP from January 2010 to December 2022. The included patients were randomized in a 7:3 ratio into training and validation cohorts. Radiomic features were extracted from semi-automatically identified infected areas in computed tomography (CT) scans and used to construct a radiomic model, which was then compared to a clinical-imaging model built with clinical and semantic CT features in terms of diagnostic performance of PCP. The combination of the radiomic model and serum β-D-glucan levels was also evaluated for PCP diagnosis.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| non-HIV patients hospitalized for suspected PCP | – | Diagnostic Test: Radiomic modelnon-HIV patients hospitalized for suspected PCP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients admitted to our institute with clinical suspected PCP
Key inclusion criteria (6 listed)
- aged over eighteen years;
- presence of an underlying disease known to be associated with PCP
- symptoms of lower respiratory tract infection, such as fever, cough or dyspnea
- signs of lung infection on high resolution CT at the on-set of the disease
- received BAL examination within three days after CT scans
Key exclusion criteria (3 listed)
- with HIV infection
- taking trimethoprim-sulfamethoxazole for prophylaxis
- undiagnosed by qPCR and IF staining tests
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 |
|---|---|---|
| Radiomic modelRadiomic model for PCP diagnosis | Diagnostic test | non-HIV patients hospitalized for suspected PCP |
Primary outcome
the diagnostic performance of radiomic model in the PCP diagnosis
Time frame: 6 months
The included patients were randomized in a 7:3 ratio into training and validation cohorts. Radiomic features were extracted from semi-automatically identified infected areas in computed tomography (CT) scans and used to construct a radiomic model. Then, the area under the curve (AUC) of the receiver operating characteristic (ROC) curves were calculated and used to evaluate the diagnostic performance (accuracy, sensitivity, specialty, positive predictive value, negative predictive value) of the model for PCP diagnosis in both training and validation cohorts.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2023.
- Derived from this study: PubMed 38167022Yu H, Yang Z, Wei Y, Shi W, Zhu M, Liu L, Wang M, Wang Y, Zhu Q, Liang Z, Zhao W, Chen LA. Computed tomography-based radiomics improves non-invasive diagnosis of Pneumocystis jirovecii pneumonia in non-HIV patients: a retrospective study. BMC Pulm Med. 2024 Jan 2;24(1):11. doi: 10.1186/s12890-023-02827-4.
- Individual participant dataSharing planned: No. Contact the researcher for requests.
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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. This study is not recruiting at the moment.
Liang-an Chen principal investigator
Chinese PLA General Hospital
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 Pneumocystis Jirovecii Pneumonia, run by Chinese PLA General Hospital 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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 27 Jan 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the diagnostic performance of radiomic model in the PCP diagnosis (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05701631, which also lists 1 linked publication.
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 27 Jan 2023.