Pulmonary Complications of Allografts

Pulmonary Complications Clinical Trial

— ALLOPULM  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01219972
• Other study ID #: CRC 04118
• Status: Completed
• Phase: N/A
• First received: October 11, 2010
• Last updated: January 3, 2017
• Start date: January 2006
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: December 2016
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Allogeneic Blood stem cell transplantation

• Alive at day 100 post-transplant

Exclusion Criteria:

• Non informed consent

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pulmonary Complications

Locations

Country	Name	City	State
France	Hôpital Saint Louis	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non infectious pulmonary complication		3 years	No
Secondary	Survival after non infectious pulmonary complication		3 years and 10 years	No
Secondary	Overall survival		3 years and 10 years	No
Secondary	Long term time course of Pulmonary Function Tests (PFTs)		3 years and 10 years	No