- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03349372
Impact of Pulmonary Follow-up After Stem Cell Graft
November 17, 2017 updated by: Hospices Civils de Lyon
Impact of Systematic Pulmonary Follow-up After Hematopoietic Stem Cell Transplantation
Allogeneic hematopoietic stem cell transplantation is the only possible treatment for many malignant and non-malignant hemopathies.
The graft-versus-host immunological reaction (GvH) is a frequent and sometimes serious complication.
The objective is to study whether a systematic and early follow-up by a lung specialist of allografted patients would allow an earlier diagnosis of GvH with pulmonary complications.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
227
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
-
-
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Lyon, France, 69004
- Croix-Rousse Hospital, Hospices Civils de Lyon
-
-
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
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All patients from Hospices Civils de Lyon, Lyon, France with blood cancer undergoing a hematopoietic stem cell transplantation between January 2013 and July 2016
Description
Inclusion Criteria:
- 18 years of age or older
- patients with a hematopoietic stem cell transplantation
Exclusion Criteria:
- Death within 100 days post-surgery
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Medical complications
Time Frame: Medical complications, especially Graft-versus-Host reaction with pulmonary complications occurring within 100 days post-surgery are studied
|
100 days after allograft
|
Medical complications, especially Graft-versus-Host reaction with pulmonary complications occurring within 100 days post-surgery are studied
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
November 1, 2016
Primary Completion (Actual)
October 31, 2017
Study Completion (Actual)
October 31, 2017
Study Registration Dates
First Submitted
November 17, 2017
First Submitted That Met QC Criteria
November 17, 2017
First Posted (Actual)
November 21, 2017
Study Record Updates
Last Update Posted (Actual)
November 21, 2017
Last Update Submitted That Met QC Criteria
November 17, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRC_GHN_2017_007
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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