Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06639750
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-10
Brief Title:
Respiratory Microbioma and Respiratory Complications After Hematopoietic Stem Cell Transplantion
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Dynamic Evaluation of Composition and Evolution of Respiratory ViromaMicrobioma of Patients Who Have Undergone Hematopoiteic Stem Cell Transplantation HSCT as a Possible Biomarker of Occurrence of Post-HSCT Pulmonary Complications
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VIREMIG
Brief Summary:
Allogeneic haematopoietic stem cell transplantation AHSCT is a therapeutic resource for many haemopathies The number of HSCTs has risen sharply in recent years due to the use of attenuated conditioning which has increased the risk of non-haematological complications Pulmonary pathologies are a frequent cause of complications following HSCA both infectious and non-infectious134
Among these late non-infectious pulmonary complications LNIPC all taken together occur in 25 of post-HSCA cases1 These NIPCs the most common of which is bronchiolitis obliterans significantly alter the prognosis45 The pathophysiology of CPTNI is poorly understood but it seems that the occurrence of a viral respiratory infection pre- or post-ACSH may be a potential trigger for the onset of CPTNI1 These viral infections can become chronic given that viral clearance is impaired by the underlying immunodepression and can thus cause chronic inflammation leading to the fibrosing and irreversible process of obliterative bronchiolitis6 Given the prognostic importance of this type of CPTNI it seems essential to gain a better understanding of its pathophysiology which may involve a number of mechanisms cellular expression of the graft and its evolution disruption of the host response innate immunity following viral infection influence of the microbiome and alteration of epithelial repair135 Interest in the digestive and respiratory microbiome has been growing in recent years7-9 The literature is gradually being enriched with data on the links between infection the microbiome and chronic respiratory pathology and in the post-HSCA context a potential link between the enteric microbiome and Chronic Graft Versus Host Disease cGVHD
A pilot study comparing respiratory microbiomes using sequencing and metatranscriptomic analysis on 20 respiratory samples nasopharyngeal swab and bronchoalveolar lavage pairs taken under the conditions of the proposed study showed that the technique was highly feasible and highly sensitive
The aim of this study is therefore to use meta-genomics to investigate the respiratory viromemicrobiome in a population of patients who have undergone HSCA eukaryotic and prokaryotic viruses bacterial expression and the expression meta-transcriptomics of graft-derived cell lines and their possible association with the occurrence of post-HSCA respiratory complications infectious and non-infectious
No study has assessed the link between the composition of the respiratory viromemicrobiome and the occurrence of respiratory events infectious and CPTNI post ACSH but also more broadly the link with the composition of the microbiome in the broad sense respiratory virome respiratory and digestive microbiota
The aim of this study is to establish a respiratory viral and bacterial map as a possible biomarker of the occurrence of respiratory events infectious and CPTNI thus enabling more personalised monitoring of patients at risk of CPTNI and management of immunosuppressive treatment of patients at risk of an infectious episode with risk assessment based on the composition of the respiratory virome
The interest of this study is that it is multidisciplinary and transdisciplinary studying the respiratory pathologies and infections of haematology patients and combining clinical and fundamental research with expected spin-offs for direct patient care personalised monitoring and management of immunosuppressive treatments
Among these late non-infectious pulmonary complications LNIPC all taken together occur in 25 of post-HSCA cases1 These NIPCs the most common of which is bronchiolitis obliterans significantly alter the prognosis45 The pathophysiology of CPTNI is poorly understood but it seems that the occurrence of a viral respiratory infection pre- or post-ACSH may be a potential trigger for the onset of CPTNI1 These viral infections can become chronic given that viral clearance is impaired by the underlying immunodepression and can thus cause chronic inflammation leading to the fibrosing and irreversible process of obliterative bronchiolitis6 Given the prognostic importance of this type of CPTNI it seems essential to gain a better understanding of its pathophysiology which may involve a number of mechanisms cellular expression of the graft and its evolution disruption of the host response innate immunity following viral infection influence of the microbiome and alteration of epithelial repair135 Interest in the digestive and respiratory microbiome has been growing in recent years7-9 The literature is gradually being enriched with data on the links between infection the microbiome and chronic respiratory pathology and in the post-HSCA context a potential link between the enteric microbiome and Chronic Graft Versus Host Disease cGVHD
A pilot study comparing respiratory microbiomes using sequencing and metatranscriptomic analysis on 20 respiratory samples nasopharyngeal swab and bronchoalveolar lavage pairs taken under the conditions of the proposed study showed that the technique was highly feasible and highly sensitive
The aim of this study is therefore to use meta-genomics to investigate the respiratory viromemicrobiome in a population of patients who have undergone HSCA eukaryotic and prokaryotic viruses bacterial expression and the expression meta-transcriptomics of graft-derived cell lines and their possible association with the occurrence of post-HSCA respiratory complications infectious and non-infectious
No study has assessed the link between the composition of the respiratory viromemicrobiome and the occurrence of respiratory events infectious and CPTNI post ACSH but also more broadly the link with the composition of the microbiome in the broad sense respiratory virome respiratory and digestive microbiota
The aim of this study is to establish a respiratory viral and bacterial map as a possible biomarker of the occurrence of respiratory events infectious and CPTNI thus enabling more personalised monitoring of patients at risk of CPTNI and management of immunosuppressive treatment of patients at risk of an infectious episode with risk assessment based on the composition of the respiratory virome
The interest of this study is that it is multidisciplinary and transdisciplinary studying the respiratory pathologies and infections of haematology patients and combining clinical and fundamental research with expected spin-offs for direct patient care personalised monitoring and management of immunosuppressive treatments
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None