Pulmonary Complications of Allografts (ALLOPULM)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01219972
First received: October 11, 2010
Last updated: November 19, 2012
Last verified: September 2010
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Survival after non infectious pulmonary complication [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 245
Study Start Date: January 2006
Study Completion Date: February 2010
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
  • Sample Size 200 transplanted patients
  • Endpoints Non infectious pulmonary complications within the first 3 years
  Eligibility

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01219972     History of Changes
Other Study ID Numbers: CRC 04118
Study First Received: October 11, 2010
Last Updated: November 19, 2012
Health Authority: France: Ministry of Health

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

ClinicalTrials.gov processed this record on April 22, 2014