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

April 28, 2020 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75019
        • Houdouin véronique

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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.
Other: late pulmonary complications occurring in children treated with allogeneic hematopoietic stem cells.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Presence of belated non-infectious pulmonary complications
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Presence of risk factors for belated non-infectious pulmonary complications
Time Frame: 3 years
3 years
Survival three years
Time Frame: 3 years
3 years
Severity of respiratory disease
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Houdouin Véronique, MD PHD, APHP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (ACTUAL)

March 30, 2020

Study Completion (ACTUAL)

March 30, 2020

Study Registration Dates

First Submitted

December 9, 2013

First Submitted That Met QC Criteria

January 8, 2014

First Posted (ESTIMATE)

January 10, 2014

Study Record Updates

Last Update Posted (ACTUAL)

April 29, 2020

Last Update Submitted That Met QC Criteria

April 28, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P120137
  • 2013-A00966-39 (OTHER: APHP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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