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

Bronchiolitis Obliterans Clinical Trial

— RESPPEDHEM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02032381
• Other study ID #: P120137
• Secondary ID: 2013-A00966-39
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: March 30, 2020

Study information

• Verified date: April 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: March 30, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
France	Houdouin véronique	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of belated non-infectious pulmonary complications		3 years
Secondary	Presence of risk factors for belated non-infectious pulmonary complications		3 years
Secondary	Survival three years		3 years
Secondary	Severity of respiratory disease		3 years