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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2020-03-30

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.

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

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

Intervention Type OTHER

Interventions

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

Intervention Type OTHER

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

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No