Radiomics Model for the Diagnosis of Pneumocystis Jirovecii Pneumonia in Non-HIV Patients

January 25, 2023 updated by: Chen Liang_An, Chinese PLA General Hospital
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100853
        • Chinese PLA General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients admitted to our institute with clinical suspected PCP

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • with HIV infection
  • taking trimethoprim-sulfamethoxazole for prophylaxis
  • undiagnosed by qPCR and IF staining tests

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
non-HIV patients hospitalized for suspected PCP
Diagnostic test: Radiomic model
Radiomic model for PCP diagnosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Investigators

  • Principal Investigator: Liang-an Chen, Chinese PLA General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2023

Primary Completion (Anticipated)

June 30, 2023

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

January 17, 2023

First Submitted That Met QC Criteria

January 25, 2023

First Posted (Actual)

January 27, 2023

Study Record Updates

Last Update Posted (Actual)

January 27, 2023

Last Update Submitted That Met QC Criteria

January 25, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S2023-006-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Contact the researcher for requests.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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