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

Assistance Publique - Hôpitaux de Paris

Status: Completed

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

Treatments: Other: late pulmonary complications occurring in children treated with allogeneic hematopoietic stem cells.

Study type: Interventional

Funder types: Other

Identifiers

NCT02032381

P120137

2013-A00966-39 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

allogeneic hematopoietic stem cell

Other group

Description:

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.

Treatment:

Other: late pulmonary complications occurring in children treated with allogeneic hematopoietic stem cells.