Prospective Study of Belated Pulmonary Complications Occurring in Children Treated With Allogeneic Hematopoietic Stem Cells.

Study Overview
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Brief Summary
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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
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It's 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.

Official Title
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Prospective Study of Late Pulmonary Complications Occurring in Children Treated With Allogeneic Hematopoietic Stem Cells.

Conditions
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Bone Marrow Transplant Infection, Bronchiolitis Obliterans, Chronic Respiratory Insufficiency, Organizing Pneumonia, Pulmonary Cytolytic Thrombi

Intervention / Treatment
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* Other: late pulmonary complications occurring in children treated with allogeneic hematopoietic stem cells.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: from birth to 18 years Patient to be treated by allogeneic hematopoietic stem cell - Parents who have given their signed consent for the study Affiliation to a social security scheme Exclusion Criteria: non exclusion criteria

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: allogeneic hematopoietic stem cell<br>The eligible population for this study will consist of all children under 18 years who received allogeneic hematopoietic stem cell and evaluate of late pulmonary complications occurring in children treated with allogeneic hematopoietic stem cells. | Other: late pulmonary complications occurring in children treated with allogeneic hematopoietic stem cells.<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of belated non-infectious pulmonary complications |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of risk factors for belated non-infectious pulmonary complications |  | 3 years | 
| Survival three years |  | 3 years | 
| Severity of respiratory disease |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non infectious pulmonary complications after hematopoietic cell transplant, functional respiratory test and exercise test, thoracic tomodensitometry