Immune Checkpoint Inhibitor Associated PneumoniaNCT06192303
Prospective Study on the Efficacy and Safety of Bronchoalveolar Lavage Combined With Pathogen Metagenomic Sequencing Technology in the Diagnosis of Immune Checkpoint Inhibitor Associated Pneumonia
An observational study of Immune Checkpoint Inhibitor Associated Pneumonia, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
Immune checkpoint inhibitor associated pneumonia (CIP) is a common immune related adverse reaction, accounting for 35% of all deaths. However, due to the lack of typical clinical symptoms and imaging manifestations, CIP needs to be differentiated from other diseases such as pulmonary infections and lung cancer… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Immune Checkpoint Inhibitor Associated Pneumonia
- What is being tested?
- Bronchoalveolar lavage and pathogen metagenomic sequencing
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 1 Jan 2026
- 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 to 75 years
- All sexes
- Adult, Older adult
Study population: 1. Failure to complete microscopic examination and culture of alveolar lavage fluid or sputum; 2. The researcher believes that there are any individuals who are not suitable for inclusion.
Who may be able to join
- Voluntarily sign an informed consent form;
- Age range from 18 to 75 years old, regardless of gender;
- Immunosuppressive host;
- Symptoms, signs, or imaging signs of pneumonia are visible, and empirical anti infection treatment is ineffective.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Southern Medical University Nanfang Hospital
Guangzhou, Guangdong
Xintong Huang, 8619355230761, 1556807596@qq.com
About this study
Immune checkpoint inhibitor associated pneumonia (CIP) is a common immune related adverse reaction, accounting for 35% of all deaths. However, due to the lack of typical clinical symptoms and imaging manifestations, CIP needs to be differentiated from other diseases such as pulmonary infections and lung cancer progression. Currently, there is a lack of diagnostic gold standards, which belongs to exclusive diagnosis. Empirical diagnosis and treatment in clinical practice can easily lead to the abuse of hormones and antibiotics, and even misdiagnosis and mistreatment, resulting in patient death. Therefore, early identification of CIP and pulmonary infection is the key to successful diagnosis and treatment. The CIP diagnosis and treatment guidelines recommend performing bronchoalveolar lavage as appropriate, but there is still a lack of large-scale prospective clinical studies. The beneficial pathogen metagenomic sequencing technology for the diagnosis of pulmonary infections has not been mentioned. Our research group conducted a prospective clinical study for the first time to evaluate the effectiveness and safety of bronchoalveolar lavage combined with pathogen metagenomic sequencing technology in diagnosing CIP, explore biomarkers for diagnosing CIP, in order to improve the early diagnosis rate and treatment efficiency of CIP, and reduce the abuse of antibiotics and hormones.
- Being tested
- Bronchoalveolar lavage and pathogen metagenomic sequencing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bronchoalveolar lavage and pathogen metagenomic sequencingDiagnostic test
After the patient is enrolled, traditional pathogen testing will be improved, and the clinical physician will make a preliminary diagnosis based on routine pathogen testing, clinical manifestations, infection indicators, and imaging. Within 24 hours of initial diagnosis, bronchoalveolar lavage and pathogen metagenomic sequencing were performed, and BALF mNGS results were fed back to clinical physicians (without interfering with clinical decision-making). Clinical treatment data of patients were collected at 72 hours, 7 days, 14 days, and 28 days after the start of treatment, and follow-up and efficacy evaluation were conducted. Finally, a review committee consisting of two senior respiratory physicians and one imaging physician conducted a systematic review of cases to make the final diagnosis of enrolled patients (as the gold standard), analyzing the accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of BALF mNGS in diagnosing CIP.
| Study group | Role | What they receive |
|---|---|---|
| CIP cohort | Not described Receives: Diagnostic Test: Bronchoalveolar lavage and pathogen metagenomic sequencing | |
| non CIP cohort | Not described Receives: Diagnostic Test: Bronchoalveolar lavage and pathogen metagenomic sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity, specificity in suspected CIP patients
Measured: 2023.01-2026.01
Positive predictive value (PPV), negative predictive value (NPV) in suspected CIP patients
Measured: 2023.01-2026.01
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start1 Jan 2023
- Primary completion1 May 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune Checkpoint Inhibitor Associated PneumoniaStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe 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
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06192303
- Sponsor's protocol ID
- NFEC-2023-276
- Status last verified
- Jan 2024
- First submitted
- 14 Dec 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study on the Efficacy and Safety of Bronchoalveolar Lavage Combined With Pathogen Metagenomic Sequencing Technology in the Diagnosis of Immune Checkpoint Inhibitor Associated Pneumonia
- ClinicalTrials.gov ID
- NCT06192303
- Acronym / sponsor ID
- NFEC-2023-276
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 5 Jan 2024 (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.
Immune checkpoint inhibitor associated pneumonia (CIP) is a common immune related adverse reaction, accounting for 35% of all deaths. However, due to the lack of typical clinical symptoms and imaging manifestations, CIP needs to be differentiated from other diseases such as pulmonary infections and lung cancer progression. Currently, there is a lack of diagnostic gold standards, which belongs to exclusive diagnosis. Empirical diagnosis and treatment in clinical practice can easily lead to the abuse of hormones and antibiotics, and even misdiagnosis and mistreatment, resulting in patient death. Therefore, early identification of CIP and pulmonary infection is the key to successful diagnosis and treatment. The CIP diagnosis and treatment guidelines recommend performing bronchoalveolar lavage as appropriate, but there is still a lack of large-scale prospective clinical studies. The beneficial pathogen metagenomic sequencing technology for the diagnosis of pulmonary infections has not been mentioned. Our research group conducted a prospective clinical study for the first time to evaluate the effectiveness and safety of bronchoalveolar lavage combined with pathogen metagenomic sequencing technology in diagnosing CIP, explore biomarkers for diagnosing CIP, in order to improve the early diagnosis rate and treatment efficiency of CIP, and reduce the abuse of antibiotics and hormones.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CIP cohort | – | Diagnostic Test: Bronchoalveolar lavage and pathogen metagenomic sequencing |
| non CIP cohort | – | Diagnostic Test: Bronchoalveolar lavage and pathogen metagenomic sequencing |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 1. Failure to complete microscopic examination and culture of alveolar lavage fluid or sputum; 2. The researcher believes that there are any individuals who are not suitable for inclusion.
Key inclusion criteria (4 listed)
- Voluntarily sign an informed consent form;
- Age range from 18 to 75 years old, regardless of gender;
- Immunosuppressive host;
- Symptoms, signs, or imaging signs of pneumonia are visible, and empirical anti infection treatment is ineffective.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Bronchoalveolar lavage and pathogen metagenomic sequencingAfter the patient is enrolled, traditional pathogen testing will be improved, and the clinical physician will make a preliminary diagnosis based on routine pathogen testing, clinical manifestations, infection indicators, and imaging. Within 24 hours of initial diagnosis, bronchoalveolar lavage and pathogen metagenomic sequencing were performed, and BALF mNGS results were fed back to clinical physicians (without interfering with clinical decision-making). Clinical treatment data of patients were collected at 72 hours, 7 days, 14 days, and 28 days after the start of treatment, and follow-up and efficacy evaluation were conducted. Finally, a review committee consisting of two senior respiratory physicians and one imaging physician conducted a systematic review of cases to make the final diagnosis of enrolled patients (as the gold standard), analyzing the accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of BALF mNGS in diagnosing CIP. | Diagnostic test | CIP cohort, non CIP cohort |
Primary outcome
Sensitivity, specificity in suspected CIP patients
Time frame: 2023.01-2026.01
Positive predictive value (PPV), negative predictive value (NPV) in suspected CIP patients
Time frame: 2023.01-2026.01
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
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.
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 Immune Checkpoint Inhibitor Associated Pneumonia, run by Nanfang Hospital, Southern Medical University 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 4 inclusion and 0 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 5 Jan 2024. 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?
Contact Xintong Huang (8619355230761, 1556807596@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity, specificity in suspected CIP patients (time frame: 2023.01-2026.01). 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 5 Jan 2024.