Inflammatory Response to Paramyxovirus Infection in an Ex-vivo Model of Bronchial Epithelial Cells in Allogeneic HSCT Recipients

NCT03684083 | Unknown

• 1 other identifier: 2017-A01325-48
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction. Chronic graft-versus-host-disease (GVHD) is the main late noninfectious complication after allogeneic hematopoietic stem cell transplantation (HSCT) that can affect several organs. Bronchiolitis obliterans syndrome (BOS) is recognized as pulmonary chronic GVHD. A diagnosis of a lower respiratory tract infection in the first 100 days following transplant has been associated to the development of BOS. One hypothesis is that the first stage driving to BOS is a previous aggression of bronchial epithelial cells by various factors such as chemotherapy and radiotherapy. Thereafter, data suggest that viral infections, in particular Parainfluenza viruses could be a trigger for BOS. The alloimmune reaction activated by the respiratory virus could lead to the fibrosis process. Our hypothesis is that the bronchial epithelium of allogeneic HSCT recipients has phenotypic specificities that are associated with a specific response to the viral respiratory infections (in particular paramyxovirus) leading to the development of BOS. Main objective. To characterize and compare the inflammatory response after infection with Parainfluenza 3 virus in an ex-vivo model of bronchial epithelial cells obtained from allogeneic HSCT recipients and controls. Objective secondary. To characterize the phenotypic specificities of allogeneic HSCT recipients' bronchial epithelium. Methodology, and experimental plan. Prospective, monocentric research. Bronchial biopsies obtained from patients, will be completely differentiated after 21 days of culture. Epithelial cells will be infected by the virus strain Parainfluenza 3. Transcriptome of the cells from both allogeneic HSCT patients and controls, infected and non-infected will be analyzed 48 hours after infection.

Conditions

Stem Cell Transplantation

Outcome Measures

Primary Outcomes (1)

• Cells Transcriptome after infection by parainfluenza virus

  inflammatory response after infection with Parainfluenza 3 virus in an ex-vivo model of bronchial epithelial cells assessed by cells transcriptome

  21 days

Study Arms (2)

Case

patients having received heterologous stem cell transplantation (HSCT)

Procedure: bronchial biopsies

Control

patients without HSCT

Procedure: bronchial biopsies

Interventions

bronchial biopsies PROCEDURE

bronchial fibroscopy with bronchial biopsies

Case; Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Case study population: patients having received Allogeneic HSCT Control study population : patients without Allogeneic HSCT

You may qualify if:

• Allogeneic HSCT patients \[case\]
• requirement of ng bronchial fibroscopy with bronchial biopsies for the exploration of FEV1 decline \[case\]
• non Allogeneic HSCT patients \[control\]
• requirement of bronchial fibroscopy for exploration of a lung mass or of interstitial lung disease, requiring bronchial biopsies \[control\]

You may not qualify if:

• Minor or major patients protected
• Radiotherapy or chemotherapy \[control group\]
• Respiratory infection
• History of smoking \>= 15 packs/yr

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Saint Louis Hospital

Paris, 75010, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

pulmonary biopsy with transcriptomic analysis after cell infection by parainfluenza virus

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2018
• First Posted: September 25, 2018
• Study Start: November 1, 2018
• Primary Completion: October 1, 2019
• Study Completion: July 1, 2020
• Last Updated: January 9, 2020

Record last verified: 2019-12

Locations

FR (1)