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

Overview

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.

Full Title of Study: “Prospective Study of Late Pulmonary Complications Occurring in Children Treated With Allogeneic Hematopoietic Stem Cells.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Screening
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 30, 2020

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.

Interventions

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

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Assistance Publique – Hôpitaux de Paris
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Houdouin Véronique, MD PHD, Principal Investigator, APHP

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