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

Primary Purpose

Bone Marrow Transplant Infection, Bronchiolitis Obliterans, Chronic Respiratory Insufficiency

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

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

About this trial

This is an interventional screening trial for Bone Marrow Transplant Infection focused on measuring non infectious pulmonary complications after hematopoietic cell transplant, functional respiratory test and exercise test, thoracic tomodensitometry

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

Houdouin véronique

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

allogeneic hematopoietic stem cell

Arm 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.

Outcomes

Primary Outcome Measures

Presence of belated non-infectious pulmonary complications

Secondary Outcome Measures

Presence of risk factors for belated non-infectious pulmonary complications

Survival three years

Severity of respiratory disease

Full Information

NCT ID

NCT02032381

First Posted

December 9, 2013

Last Updated

April 28, 2020

Sponsor

Assistance Publique - Hôpitaux de Paris

1. Study Identification

Unique Protocol Identification Number

NCT02032381

Brief Title

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

Acronym

RESPPEDHEM

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Completed

Study Start Date

January 2014 (undefined)

Primary Completion Date

March 30, 2020 (Actual)

Study Completion Date

March 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

300 (Actual)

8. Arms, Groups, and Interventions

Arm Title

allogeneic hematopoietic stem cell

Arm Type

Other

Arm Description

Intervention Type

Other

Intervention Name(s)

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

Primary Outcome Measure Information:

Title

Presence of belated non-infectious pulmonary complications

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Presence of risk factors for belated non-infectious pulmonary complications

Time Frame

3 years

Title

Survival three years

Time Frame

3 years

Title

Severity of respiratory disease

Time Frame

3 years

10. Eligibility

Sex

All

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Houdouin Véronique, MD PHD

Organizational Affiliation

APHP

Official's Role

Principal Investigator

Facility Information:

Facility Name

Houdouin véronique

City

Paris

ZIP/Postal Code

75019

Country

France

12. IPD Sharing Statement

Learn more about this trial

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

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