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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02032381
Recruitment Status : Active, not recruiting
First Posted : January 10, 2014
Last Update Posted : November 18, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE December 9, 2013
First Posted Date  ICMJE January 10, 2014
Last Update Posted Date November 18, 2019
Study Start Date  ICMJE January 2014
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 8, 2014)
Presence of belated non-infectious pulmonary complications [ Time Frame: 3 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 8, 2014)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prospective Study of Belated Pulmonary Complications Occurring in Children Treated With Allogeneic Hematopoietic Stem Cells.
Official Title  ICMJE Prospective Study of Late Pulmonary Complications Occurring in Children Treated With Allogeneic Hematopoietic Stem Cells.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE
  • Bone Marrow Transplant Infection
  • Bronchiolitis Obliterans
  • Chronic Respiratory Insufficiency
  • Organizing Pneumonia
  • Pulmonary Cytolytic Thrombi
Intervention  ICMJE Other: late pulmonary complications occurring in children treated with allogeneic hematopoietic stem cells.
Study Arms  ICMJE 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.
Intervention: Other: late pulmonary complications occurring in children treated with allogeneic hematopoietic stem cells.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 18, 2018)
300
Original Estimated Enrollment  ICMJE
 (submitted: January 8, 2014)
500
Estimated Study Completion Date  ICMJE January 2020
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02032381
Other Study ID Numbers  ICMJE P120137
2013-A00966-39 ( Other Identifier: APHP )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Houdouin Véronique, MD PHD APHP
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP