NCT02032381

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2013

Completed
23 days until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 10, 2014

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
Last Updated

April 29, 2020

Status Verified

April 1, 2020

Enrollment Period

6.2 years

First QC Date

December 9, 2013

Last Update Submit

April 28, 2020

Conditions

Bone Marrow Transplant InfectionBronchiolitis ObliteransChronic Respiratory InsufficiencyOrganizing PneumoniaPulmonary Cytolytic Thrombi

Keywords

non infectious pulmonary complications after hematopoietic cell transplantfunctional respiratory test and exercise testthoracic tomodensitometry

Outcome Measures

Primary Outcomes (1)

  • Presence of belated non-infectious pulmonary complications

    3 years

Secondary Outcomes (3)

  • Presence of risk factors for belated non-infectious pulmonary complications

    3 years

  • Survival three years

    3 years

  • Severity of respiratory disease

    3 years

Study Arms (1)

allogeneic hematopoietic stem cell

OTHER

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.

Interventions

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

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Houdouin véronique

Paris, 75019, France

Location

Related Publications (2)

  • Houdouin V, Feghali H, Boileau S, Guinot M, Reix P, Pages J, Crepon SG, Delclaux C. Prospective Evaluation of Cardiorespiratory Fitness After Hematopoietic Stem Cell Transplantation in Children. Pediatr Pulmonol. 2025 May;60(5):e70994. doi: 10.1002/ppul.70994.

    PMID: 40371796DERIVED

  • Houdouin V, Dubus JC, Crepon SG, Rialland F, Bruno B, Jubert C, Reix P, Pasquet M, Paillard C, Adjaoud D, Schweitzer C, Le Bourgeois M, Pages J, Yacoubi A, Dalle JH, Bergeron A, Delclaux C. Late-onset pulmonary complications following allogeneic hematopoietic cell transplantation in pediatric patients: a prospective multicenter study. Bone Marrow Transplant. 2024 Jun;59(6):858-866. doi: 10.1038/s41409-024-02258-7. Epub 2024 Mar 7.

    PMID: 38454132DERIVED

MeSH Terms

Conditions

Bronchiolitis ObliteransOrganizing Pneumonia

Condition Hierarchy (Ancestors)

BronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Study Officials

  • Houdouin Véronique, MD PHD

    APHP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2013

First Posted

January 10, 2014

Study Start

January 1, 2014

Primary Completion

March 30, 2020

Study Completion

March 30, 2020

Last Updated

April 29, 2020

Record last verified: 2020-04

Locations

FR(1)