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Pulmonary Complications of Allografts (ALLOPULM)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01219972
First Posted: October 13, 2010
Last Update Posted: January 4, 2017
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.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  Purpose
This is a prognostic study of the late lung complications arising at the patient's having received an allograft of hematopoetic stem cells.

Condition
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)
Groups/Cohorts
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
  Eligibility

Information from the National Library of Medicine

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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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Non informed consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01219972


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

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01219972     History of Changes
Other Study ID Numbers: CRC 04118
First Submitted: October 11, 2010
First Posted: October 13, 2010
Last Update Posted: January 4, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Bone marrow transplant
Pulmonary complications