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Pulmonary Complications of Allografts (ALLOPULM)

This study has been completed.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris Identifier:
First received: October 11, 2010
Last updated: January 3, 2017
Last verified: December 2016
This is a prognostic study of the late lung complications arising at the patient's having received an allograft of hematopoetic stem cells.

Pulmonary Complications

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Cohort Study of Late Pulmonary Complications in Patients Who Received Allogeneic Hematopoietic Stem Cells Transplantation: Estimation of Incidence and Identification of Distinct Nosologic Entities

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

Primary Outcome Measures:
  • Non infectious pulmonary complication [ Time Frame: 3 years ]

Secondary Outcome Measures:
  • Survival after non infectious pulmonary complication [ Time Frame: 3 years and 10 years ]
  • Overall survival [ Time Frame: 3 years and 10 years ]
  • Long term time course of Pulmonary Function Tests (PFTs) [ Time Frame: 3 years and 10 years ]

Enrollment: 245
Study Start Date: January 2006
Study Completion Date: December 2016
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
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

Detailed Description:
  • Objectives To estimate the incidence of late (at least occurring 100 days after transplantation) pulmonary complications following allogeneic blood stem cells transplantation
  • Study Design Prospective Cohort Study All follow-up data were actualiized in September, 2016.
  • Sample Size 200 transplanted patients
  • Main Endpoint Non infectious pulmonary complications within the first 3 years

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who underwent a allogeneic blood stem cell transplantation, alive at 100 days post-transplantation

Inclusion Criteria:

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

Exclusion Criteria:

  • Non informed consent
  Contacts and Locations
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Please refer to this study by its identifier: NCT01219972

Hôpital Saint Louis
Paris, France, 75010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Principal Investigator: Anne Bergeron - Laffaurie,, PhDMD Assistance Publique - Hôpitaux de Paris
  More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT01219972     History of Changes
Other Study ID Numbers: CRC 04118
Study First Received: October 11, 2010
Last Updated: January 3, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Bone marrow transplant
Pulmonary complications processed this record on April 28, 2017