Diagnosis of Lung Complication After Allo-HSCT by Multiple Parameter System Through BAL

Lung Infection Clinical Trial

— SHSYXY-BAL  

Official title:

Diagnosis of Lung Complication After Allogeneic Hematopoietic Stem Cell Transplantation by Multiple Parameter System Through Bronchoscopic Alveolar Lavage

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04051372
• Other study ID #: 2018KY270
• Status: Not yet recruiting
• Start date: August 30, 2019
• Est. completion date: March 30, 2022

Study information

• Verified date: August 2019
• Source: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: xianmin song, M.D.
• Phone: 86-21-37798987
• Email: shongxm[@]139.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

Description:

一) 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

二) The BALF samples were tested using such methods

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

三) Pathogenic spectrum analysis and Targeted etiological therapy

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: March 30, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Diagnosed with hematological diseases.

2. Recipients of allogeneic peripheral blood stem cell transplantation.

3. Lung infiltration detection at computed tomography (CT) scan.

4. Patients with fever, cough, respiratory symptoms.

5. Consent to BAL and follow-up observation after BAL

Exclusion Criteria:

1. Severe bleeding tendency, platelet less than 20000/uL, or severe coagulation dysfunction;

2. Multiple bullae are at risk of rupture;

3. Untreated patients with active pulmonary tuberculosis;

4. Patients with severe consumptive diseases or conditions and various causes can not cooperate well

5. Cardiac insufficiency, severe pulmonary ventilation dysfunction

6. Recent massive hemoptysis

7. Aortic aneurysm and esophageal varices are at risk of rupture

Related Conditions & MeSH terms

• Bronchoalveolar Lavage Fluid
• Lung Infection

Intervention

Diagnostic Test:
• Bronchoscopic Alveolar Lavage
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall response rate	Efficiency of treatment for pulmonary complications after allo-HSCT	100 days after BAL
Secondary	microbiology diagnostic yields	Comparing the pathogenic detection rate by BALF with non-invasive detection method	100 days after BAL
Secondary	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	30-day and 100-day after BAL