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

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.

Study Overview

• Status: Unknown
• Conditions: Lung Infection; Bronchoalveolar Lavage Fluid
• Intervention / Treatment: Diagnostic test: Bronchoscopic Alveolar Lavage

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

• Study Type: Observational
• Enrollment (Anticipated): 250

Contacts and Locations

• Study Contact: Name: xianmin song, M.D.; Phone Number: 86-21-37798987; Email: shongxm@139.com
• Study Contact Backup: Name: su li; Phone Number: 86-21-37798987; Email: lisuabcd@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

BAL group; 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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall response rate	Efficiency of treatment for pulmonary complications after allo-HSCT	100 days after BAL

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
microbiology diagnostic yields	Comparing the pathogenic detection rate by BALF with non-invasive detection method	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	30-day and 100-day after BAL

Collaborators and Investigators

• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Anticipated): August 30, 2019
• Primary Completion (Anticipated): March 30, 2022
• Study Completion (Anticipated): March 30, 2022

Study Registration Dates

• First Submitted: August 8, 2019
• First Submitted That Met QC Criteria: August 8, 2019
• First Posted (Actual): August 9, 2019

Study Record Updates

• Last Update Posted (Actual): August 9, 2019
• Last Update Submitted That Met QC Criteria: August 8, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Invasive Pulmonary Aspergillosis; Idiopathic Pneumonia Syndrome; CMV Pneumonia; Pneumocystis Jiroveci Pneumonia
• Other Study ID Numbers: 2018KY270

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No