Ignite Creation Date:
2024-05-06 @ 2:25 AM
Last Modification Date:
2024-10-26 @ 11:17 AM
Study NCT ID:
NCT02032381
Status:
COMPLETED
Last Update Posted:
2020-04-29
First Post:
2013-12-09
Brief Title:
Prospective Study of Belated Pulmonary Complications Occurring in Children Treated With Allogeneic Hematopoietic Stem Cells
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Prospective Study of Late Pulmonary Complications Occurring in Children Treated With Allogeneic Hematopoietic Stem Cells
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RESPPEDHEM
Brief Summary:
Hematopoietic stem cell transplantation HSCT is used to treat an expanding array of malignant and non-malignant disorders This is a prospective multicenter study in pediatric allo-BMT recipients to analyze the spectrum of noninfectious pulmonary complications PC to evaluate the prevalence and course of PFT abnormalities before and after transplant and to detect risk factor for PC
Detailed Description:
Its a multicenter prospective study in France All children under 18 years are included just before the HSCT The functional test before the HSCT at 6 12 18 24 30 and 36 months will be collected and a cardiopulmonary exercise test is done one and three years after the HSCT Thoracic tomodensitometry is done before the HCT and after at 6 12 24 and 36 months
All data will be collected upon the HSCT the infections before and after the HSCT the respiratory symptoms and the treatment Bronchia alveolar lavage and serum will be collected and frozen during the study
The inclusion will be done during two years and children will be following during three years
The purpose is to evaluate the prevalence the course of PFT abnormalities before and after transplant and to detect risk factor for PC
All data will be collected upon the HSCT the infections before and after the HSCT the respiratory symptoms and the treatment Bronchia alveolar lavage and serum will be collected and frozen during the study
The inclusion will be done during two years and children will be following during three years
The purpose is to evaluate the prevalence the course of PFT abnormalities before and after transplant and to detect risk factor for PC
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2013-A00966-39 | OTHER | APHP | None |