Pulmonary Complications of Allografts (ALLOPULM)

January 3, 2017 updated by: Assistance Publique - Hôpitaux de Paris

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

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

Study Overview

Status

Completed

Conditions

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

Study Type

Observational

Enrollment (Actual)

245

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75010
        • Hopital Saint Louis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who underwent a allogeneic blood stem cell transplantation, alive at 100 days post-transplantation

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Non informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Non infectious pulmonary complication
Time Frame: 3 years
3 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Anne Bergeron - Laffaurie,, PhDMD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (ACTUAL)

February 1, 2009

Study Completion (ACTUAL)

December 1, 2016

Study Registration Dates

First Submitted

October 11, 2010

First Submitted That Met QC Criteria

October 12, 2010

First Posted (ESTIMATE)

October 13, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

January 4, 2017

Last Update Submitted That Met QC Criteria

January 3, 2017

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CRC 04118

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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