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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02032381
Acronym
RESPPEDHEM
Enrollment
300
Registered
2014-01-10
Start date
2014-01-31
Completion date
2020-03-30
Last updated
2020-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

non infectious pulmonary complications after hematopoietic cell transplant, functional respiratory test and exercise test, thoracic tomodensitometry

Brief 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.

Interventions

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

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Presence of belated non-infectious pulmonary complications3 years

Secondary

MeasureTime frame
Presence of risk factors for belated non-infectious pulmonary complications3 years
Survival three years3 years
Severity of respiratory disease3 years

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026