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

This study is currently recruiting participants.
Verified October 2016 by Assistance Publique - Hôpitaux de Paris
Sponsor:
ClinicalTrials.gov Identifier:
NCT02032381
First Posted: January 10, 2014
Last Update Posted: October 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  Purpose
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.

Condition Intervention
Bone Marrow Transplant Infection Bronchiolitis Obliterans Chronic Respiratory Insufficiency Organizing Pneumonia Pulmonary Cytolytic Thrombi Other: late pulmonary complications occurring in children treated with allogeneic hematopoietic stem cells.

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Prospective Study of Late Pulmonary Complications Occurring in Children Treated With Allogeneic Hematopoietic Stem Cells.

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Presence of belated non-infectious pulmonary complications [ Time Frame: 3 years ]

Secondary Outcome Measures:
  • Presence of risk factors for belated non-infectious pulmonary complications [ Time Frame: 3 years ]
  • Survival three years [ Time Frame: 3 years ]
  • Severity of respiratory disease [ Time Frame: 3 years ]

Estimated Enrollment: 500
Study Start Date: January 2014
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02032381


Contacts
Contact: Houdouin veronique, MD PHD 0140033678 veronique.houdouin@rdb.aphp.fr

Locations
France
Houdouin véronique Recruiting
Paris, France, 75019
Contact: houdouin véronique, MD PHD    0140033678    veronique.houdouin@rdb.aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Houdouin Véronique, MD PHD APHP
  More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02032381     History of Changes
Other Study ID Numbers: P120137
2013-A00966-39 ( Other Identifier: APHP )
First Submitted: December 9, 2013
First Posted: January 10, 2014
Last Update Posted: October 12, 2016
Last Verified: October 2016

Keywords provided by Assistance Publique - Hôpitaux de Paris:
non infectious pulmonary complications after hematopoietic cell transplant
functional respiratory test and exercise test
thoracic tomodensitometry

Additional relevant MeSH terms:
Pneumonia
Bronchiolitis
Thrombosis
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Bronchiolitis Obliterans
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Bronchitis
Bronchial Diseases
Lung Diseases, Obstructive
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Respiration Disorders
Heart Valve Diseases
Heart Diseases