NCT01219972

Brief Summary

This is a prognostic study of the late lung complications arising at the patient's having received an allograft of hematopoetic stem cells.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
245

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2006

Longer than P75 for all trials

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

Study Start

First participant enrolled

January 1, 2006

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 11, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 13, 2010

Completed
6.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 4, 2017

Status Verified

December 1, 2016

Enrollment Period

3.1 years

First QC Date

October 11, 2010

Last Update Submit

January 3, 2017

Conditions

Pulmonary Complications

Keywords

Bone marrow transplantPulmonary complications

Outcome Measures

Primary Outcomes (1)

  • Non infectious pulmonary complication

    3 years

Secondary Outcomes (3)

  • Survival after non infectious pulmonary complication

    3 years and 10 years

  • Overall survival

    3 years and 10 years

  • Long term time course of Pulmonary Function Tests (PFTs)

    3 years and 10 years

Study Arms (1)

Allografted patients

* All consecutive patients who underwent an allogeneic blood stem cells transplantation performed at saint Louis hospital during the study recruitment period * if alive at 100 days post-transplant * and who gave informed consent

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent a allogeneic blood stem cell transplantation, alive at 100 days post-transplantation

You may qualify if:

  • Allogeneic Blood stem cell transplantation
  • Alive at day 100 post-transplant

You may not qualify if:

  • Non informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Saint Louis

Paris, Paris, 75010, France

Location

Related Publications (1)

  • Bergeron A, Chevret S, Peffault de Latour R, Chagnon K, de Margerie-Mellon C, Riviere F, Robin M, Mani J, Lorillon G, Socie G, Tazi A. Noninfectious lung complications after allogeneic haematopoietic stem cell transplantation. Eur Respir J. 2018 May 3;51(5):1702617. doi: 10.1183/13993003.02617-2017. Print 2018 May.

    PMID: 29650555DERIVED

Study Officials

  • Anne Bergeron - Laffaurie,, PhDMD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2010

First Posted

October 13, 2010

Study Start

January 1, 2006

Primary Completion

February 1, 2009

Study Completion

December 1, 2016

Last Updated

January 4, 2017

Record last verified: 2016-12

Locations

FR(1)