Bronchoalveolar Lavage FluidSHSYXY-BALNCT04051372
Diagnosis of Lung Complication After Allo-HSCT by Multiple Parameter System Through BAL
An observational study of Bronchoalveolar Lavage Fluid and Lung Infection, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine.
Trial summary
The aim of this study was to evaluate the diagnostic yield for lung complication after allo-HSCT by multiple parameter system through BAL. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Bronchoalveolar Lavage Fluid, Lung Infection
- What is being tested?
- Bronchoscopic Alveolar Lavage
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 30 Aug 2019to 30 Mar 2022
- How long will I take part?
- 100 Days
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: High morbidity and mortality in patient receiving hematopoietic Stem Cell Transplantation (HSCT) are resulted from lung complications. Diagnosis of the etiology affects the choice of treatment. The bronchoalveolar lavage (BAL) analysis is safe and widely accepted, which provide valuable information for pathogen identification in pulmonary infections diagnosis.
Who may be able to join
- Diagnosed with hematological diseases.
- Recipients of allogeneic peripheral blood stem cell transplantation.
- Lung infiltration detection at computed tomography (CT) scan.
- Patients with fever, cough, respiratory symptoms.
- Consent to BAL and follow-up observation after BAL
Who cannot join
- Severe bleeding tendency, platelet less than 20000/uL, or severe coagulation dysfunction;
- Multiple bullae are at risk of rupture;
- Untreated patients with active pulmonary tuberculosis;
- Patients with severe consumptive diseases or conditions and various causes can not cooperate well
- Cardiac insufficiency, severe pulmonary ventilation dysfunction
- Recent massive hemoptysis
- Aortic aneurysm and esophageal varices are at risk of rupture
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Diagnosis of Lung Complication After Allogeneic Hematopoietic Stem Cell Transplantation by Multiple Parameter System Through Bronchoscopic Alveolar Lavage
The aim of this study was to evaluate the diagnostic yield for lung complication after allo-HSCT by multiple parameter system through BAL.
Read the detailed description
一) Adult patients with hematology disease under allo-HSCT at any phase of treatment are enrolled according to the following criteria:
- lung infiltration detection at computed tomography (CT) scan.
- Patients with fever, cough, respiratory symptoms. According to the investigators, the patients fulfilling these criteria undergo BAL as soon as possible
二) The BALF samples were tested using such methods
- classic microbiological cultures designed for bacteria, fungi, and mycobacteria.
- Detection of human cytomegalovirus (CMV) and EB virus in serum and BAL was tested using a Real-time PCR kit.
- Detection of aspergillus galactomannan antigen 1,3-beta-D-glucan in serum and BAL was performed using an enzyme immunoassay method.
- Cytological and pathogenic microscopic evaluation in BALF
- Flow cytological analysis of T lymphocyte subsets in BALF and serum
- Cytokine detection in BALF and serum
- Microbiology detection in BALF by mNGS
三) Pathogenic spectrum analysis and Targeted etiological therapy
- Conditions
- Bronchoalveolar Lavage Fluid, Lung Infection
- Being tested
- Bronchoscopic Alveolar Lavage
- Keywords
- Idiopathic Pneumonia Syndrome, CMV Pneumonia, Pneumocystis Jiroveci Pneumonia, Invasive Pulmonary Aspergillosis
- Medical subject headings
- Pneumonia, Pneumocystis, Invasive Pulmonary Aspergillosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bronchoscopic Alveolar LavageDiagnostic test
The diagnostic yield of different diagnostic methods for lung infection and non-infectious diseases under allo-HSCT patients.
- Classic microbiological cultures designed for bacteria, fungi, and mycobacteria.
- Detection of human cytomegalovirus (CMV) and EB virus in serum and BAL was tested using a Real-time PCR kit.
- Detection of aspergillus galactomannan antigen 1,3-beta-D-glucan in serum and BAL was performed using an enzyme immunoassay method.
- Cytological and pathogenic microscopic evaluation in BALF
- Flow cytological analysis of T lymphocyte subsets in BALF and serum
- Cytokine detection in BALF and serum
- Microbiology detection in BALF by mNGS
| Study group | Role | What they receive |
|---|---|---|
| BAL group | Adult patients with hematology disease under allo-HSCT at any phase of treatment are enrolled according to the following criteria:
1. lung infiltration detection at computed tomography (CT) scan.
2. Patients with fever, cough, respiratory symptoms. According to the investigators, the patients fulfilling these criteria undergo BAL as soon as possible Receives: Diagnostic Test: Bronchoscopic Alveolar Lavage |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall response rate
Efficiency of treatment for pulmonary complications after allo-HSCT
Measured: 100 days after BAL
Secondary outcomes (2)
microbiology diagnostic yields
Comparing the pathogenic detection rate by BALF with non-invasive detection method
Measured: 100 days after BAL
all-cause mortality and attributable mortality of pulmonary complications
30-day and 100-day mortality (including all-cause mortality and attributable mortality of pulmonary complications) in patients undergoing BAL
Measured: 30-day and 100-day after BAL
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2019
- Study start30 Aug 2019 (estimated)
- Primary completion30 Mar 2022 (estimated)
- Study completion30 Mar 2022 (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 Bronchoalveolar Lavage FluidStudies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe 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
- 250 participants (estimated)
- Target duration
- 100 Days
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xianmin Song, MD, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- xianmin song, M.D., Principal investigator, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04051372
- Sponsor's protocol ID
- 2018KY270
- Acronym
- SHSYXY-BAL
- Status last verified
- Aug 2019
- First submitted
- 8 Aug 2019
- Last updated
- 9 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shen Z, Wang Y, Bao A, Yang J, Sun X, Cai Y, Wan L, Huang C, Xu X, Niu J, Xia X, Shen C, Wei Y, Qiu H, Zhou K, Zhang M, Tong Y, Song X. Metagenomic Next-Generation Sequencing for Pathogens in Bronchoalveolar Lavage Fluid Improves the Survival of Patients with Pulmonary Complications After Allogeneic Hematopoietic Stem Cell Transplantation. Infect Dis Ther. 2023 Aug;12(8):2103-2115. doi: 10.1007/s40121-023-00850-w. Epub 2023 Aug 4.
PubMed 37541984
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Lung Complication After Allogeneic Hematopoietic Stem Cell Transplantation by Multiple Parameter System Through Bronchoscopic Alveolar Lavage
- ClinicalTrials.gov ID
- NCT04051372
- Acronym / sponsor ID
- SHSYXY-BAL / 2018KY270
- Conditions
- Bronchoalveolar Lavage Fluid, Lung Infection
- Keywords
- Idiopathic Pneumonia Syndrome, CMV Pneumonia, Pneumocystis Jiroveci Pneumonia, Invasive Pulmonary Aspergillosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 30 Aug 2019 (estimated)
- Primary completion
- 30 Mar 2022 (estimated)
- Study completion
- 30 Mar 2022 (estimated)
- First posted
- 9 Aug 2019 (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.
The aim of this study was to evaluate the diagnostic yield for lung complication after allo-HSCT by multiple parameter system through BAL.
Detailed description
一) Adult patients with hematology disease under allo-HSCT at any phase of treatment are enrolled according to the following criteria:
- lung infiltration detection at computed tomography (CT) scan.
- Patients with fever, cough, respiratory symptoms. According to the investigators, the patients fulfilling these criteria undergo BAL as soon as possible
二) The BALF samples were tested using such methods
- classic microbiological cultures designed for bacteria, fungi, and mycobacteria.
- Detection of human cytomegalovirus (CMV) and EB virus in serum and BAL was tested using a Real-time PCR kit.
- Detection of aspergillus galactomannan antigen 1,3-beta-D-glucan in serum and BAL was performed using an enzyme immunoassay method.
- Cytological and pathogenic microscopic evaluation in BALF
- Flow cytological analysis of T lymphocyte subsets in BALF and serum
- Cytokine detection in BALF and serum
- Microbiology detection in BALF by mNGS
三) Pathogenic spectrum analysis and Targeted etiological therapy
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 100 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BAL group | – | Diagnostic Test: Bronchoscopic Alveolar LavageAdult patients with hematology disease under allo-HSCT at any phase of treatment are enrolled according to the following criteria: 1. lung infiltration detection at computed tomography (CT) scan. 2. Patients with fever, cough, respiratory symptoms. According to the investigators, the patients fulfilling these criteria undergo BAL as soon as possible |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- High morbidity and mortality in patient receiving hematopoietic Stem Cell Transplantation (HSCT) are resulted from lung complications. Diagnosis of the etiology affects the choice of treatment. The bronchoalveolar lavage (BAL) analysis is safe and widely accepted, which provide valuable information for pathogen identification in pulmonary infections diagnosis.
Key inclusion criteria (5 listed)
- Diagnosed with hematological diseases.
- Recipients of allogeneic peripheral blood stem cell transplantation.
- Lung infiltration detection at computed tomography (CT) scan.
- Patients with fever, cough, respiratory symptoms.
- Consent to BAL and follow-up observation after BAL
Key exclusion criteria (7 listed)
- Severe bleeding tendency, platelet less than 20000/uL, or severe coagulation dysfunction;
- Multiple bullae are at risk of rupture;
- Untreated patients with active pulmonary tuberculosis;
- Patients with severe consumptive diseases or conditions and various causes can not cooperate well
- Cardiac insufficiency, severe pulmonary ventilation dysfunction
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 |
|---|---|---|
| Bronchoscopic Alveolar LavageThe diagnostic yield of different diagnostic methods for lung infection and non-infectious diseases under allo-HSCT patients. 1. Classic microbiological cultures designed for bacteria, fungi, and mycobacteria. 2. Detection of human cytomegalovirus (CMV) and EB virus in serum and BAL was tested using a Real-time PCR kit. 3. Detection of aspergillus galactomannan antigen 1,3-beta-D-glucan in serum and BAL was performed using an enzyme immunoassay method. 4. Cytological and pathogenic microscopic evaluation in BALF 5. Flow cytological analysis of T lymphocyte subsets in BALF and serum 6. Cytokine detection in BALF and serum 7. Microbiology detection in BALF by mNGS | Diagnostic test | BAL group |
Primary outcome
overall response rate
Time frame: 100 days after BAL
Efficiency of treatment for pulmonary complications after allo-HSCT
2 secondary outcomes
microbiology diagnostic yields
Time frame: 100 days after BAL
all-cause mortality and attributable mortality of pulmonary complications
Time frame: 30-day and 100-day after BAL
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2019.
- Derived from this study: PubMed 37541984Shen Z, Wang Y, Bao A, Yang J, Sun X, Cai Y, Wan L, Huang C, Xu X, Niu J, Xia X, Shen C, Wei Y, Qiu H, Zhou K, Zhang M, Tong Y, Song X. Metagenomic Next-Generation Sequencing for Pathogens in Bronchoalveolar Lavage Fluid Improves the Survival of Patients with Pulmonary Complications After Allogeneic Hematopoietic Stem Cell Transplantation. Infect Dis Ther. 2023 Aug;12(8):2103-2115. doi: 10.1007/s40121-023-00850-w. Epub 2023 Aug 4.
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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.
xianmin song, M.D. principal investigator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchoalveolar Lavage Fluid and Lung Infection, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine.
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 5 inclusion and 7 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 9 Aug 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact xianmin song, M.D. (86-21-37798987, shongxm@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall response rate (time frame: 100 days after BAL). 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 NCT04051372, 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 9 Aug 2019.