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

• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04051372
• Collaborator: (none)
• Enrollment: 250
• Anticipated Duration (Months): 31

Study Details

Study Description

Brief Summary

The aim of this study was to evaluate the diagnostic yield for lung complication after allo-HSCT by multiple parameter system through BAL.

Condition or Disease	Intervention/Treatment	Phase
Bronchoalveolar Lavage Fluid; Lung Infection	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 Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 250 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Diagnosis of Lung Complication After Allogeneic Hematopoietic Stem Cell Transplantation by Multiple Parameter System Through Bronchoscopic Alveolar Lavage
• Anticipated Study Start Date: Aug 30, 2019
• Anticipated Primary Completion Date: Mar 30, 2022
• Anticipated Study Completion Date: Mar 30, 2022

Arms and Interventions

Arm

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

Outcome Measures

Primary Outcome Measures

1. overall response rate [100 days after BAL]

   Efficiency of treatment for pulmonary complications after allo-HSCT

Secondary Outcome Measures

1. microbiology diagnostic yields [100 days after BAL]

   Comparing the pathogenic detection rate by BALF with non-invasive detection method

2. all-cause mortality and attributable mortality of pulmonary complications [30-day and 100-day after BAL]

   30-day and 100-day mortality (including all-cause mortality and attributable mortality of pulmonary complications) in patients undergoing BAL

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

• Principal Investigator: xianmin song, M.D., Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xianmin Song, MD, Director, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• ClinicalTrials.gov Identifier: NCT04051372
• Other Study ID Numbers: 2018KY270
• First Posted: Aug 9, 2019
• Last Update Posted: Aug 9, 2019
• Last Verified: Aug 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Xianmin Song, MD, Director, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: Idiopathic Pneumonia Syndrome; CMV Pneumonia; Pneumocystis Jiroveci Pneumonia; Invasive Pulmonary Aspergillosis

Study Results

No Results Posted as of Aug 9, 2019