Trials / Completed
CompletedNCT02032381
Prospective Study of Belated Pulmonary Complications Occurring in Children Treated With Allogeneic Hematopoietic Stem Cells.
Prospective Study of Late Pulmonary Complications Occurring in Children Treated With Allogeneic Hematopoietic Stem Cells.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 300 (actual)
- Sponsor
- Assistance Publique - Hôpitaux de Paris · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
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.
Conditions
- Bone Marrow Transplant Infection
- Bronchiolitis Obliterans
- Chronic Respiratory Insufficiency
- Organizing Pneumonia
- Pulmonary Cytolytic Thrombi
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | late pulmonary complications occurring in children treated with allogeneic hematopoietic stem cells. |
Timeline
- Start date
- 2014-01-01
- Primary completion
- 2020-03-30
- Completion
- 2020-03-30
- First posted
- 2014-01-10
- Last updated
- 2020-04-29
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT02032381. Inclusion in this directory is not an endorsement.