Prospective Study of Belated Pulmonary Complications Occurring in Children Treated With Allogeneic Hematopoietic Stem Cells. (RESPPEDHEM)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02032381|
Recruitment Status : Recruiting
First Posted : January 10, 2014
Last Update Posted : October 12, 2016
|Condition or disease||Intervention/treatment||Phase|
|Bone Marrow Transplant Infection Bronchiolitis Obliterans Chronic Respiratory Insufficiency Organizing Pneumonia Pulmonary Cytolytic Thrombi||Other: late pulmonary complications occurring in children treated with allogeneic hematopoietic stem cells.||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Study of Late Pulmonary Complications Occurring in Children Treated With Allogeneic Hematopoietic Stem Cells.|
|Study Start Date :||January 2014|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||January 2019|
allogeneic hematopoietic stem cell
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.|
- Presence of belated non-infectious pulmonary complications [ Time Frame: 3 years ]
- Presence of risk factors for belated non-infectious pulmonary complications [ Time Frame: 3 years ]
- Survival three years [ Time Frame: 3 years ]
- Severity of respiratory disease [ Time Frame: 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02032381
|Contact: Houdouin veronique, MD PHDemail@example.com|
|Paris, France, 75019|
|Contact: houdouin véronique, MD PHD 0140033678 firstname.lastname@example.org|
|Principal Investigator:||Houdouin Véronique, MD PHD||APHP|