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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 23, 2014