NCT04051372

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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: 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

Conditions

• Bronchoalveolar Lavage Fluid
• Lung Infection

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Bronchoscopic Alveolar Lavage	The 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

Timeline

• Start date: 2019-08-30
• Primary completion: 2022-03-30
• Completion: 2022-03-30
• First posted: 2019-08-09
• Last updated: 2019-08-09