- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01420172
Pulmonary Disease in Patients Undergoing Hematopoietic Stem Cell Transplantation
February 24, 2017 updated by: Karen Wood
Pulmonary Disease in Patients Undergoing Hematopoietic Stem Cell Transplantation.
This will be a retrospective study and analysis of subjects who have undergone a hematopoietic stem transplant (either at OSUMC or external location) and were seen at OSUMC at any time between 01Jan2000 and 30Jun2011.
This study will determine factors influencing pulmonary disease and associated treatment strategies.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
200
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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Ohio
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Columbus, Ohio, United States, 43221
- The Ohio State University Medical Center
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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
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
A patient record captured during 01Jan2000 and 30Jun2011 from the medical record at The Ohio State University Medical Center who were seen post hematopoietic stem transplant.
Description
Inclusion Criteria:
- Adult patients who have undergone a hematopoietic stem transplant (either at OSUMC or external location) and were seen at OSUMC at any time between 01Jan2000 and 30Jun2011.
- Age > 18 years
Exclusion Criteria:
- Age <18 years
- Prisoners
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 |
Intervention / Treatment |
---|---|
Post hematopoietic stem cell transplantation
Patients who were seen post hematopoietic stem cell transplantation between 01Jan2000 and 30Jun2011
|
Collection of data on patients who were seen at OSUMC at any time between 01Jan2000 and 30Jun2011 post hematopoietic stem cell transplantation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
A retrospective diagnostic review on pulmonary disease related to hematopoietic stem cell transplantation.
Time Frame: Up to 15 years
|
To determine factors influencing pulmonary disease related to HSCT.
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Up to 15 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
A retrospective treatment review on treatment strategies for pulmonary disease related to hematopoietic stem cell transplantation.
Time Frame: Up to 15 years
|
To review treatment strategies for pulmonary disease post transplant for effectiveness.
|
Up to 15 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
- Williams KM, Chien JW, Gladwin MT, Pavletic SZ. Bronchiolitis obliterans after allogeneic hematopoietic stem cell transplantation. JAMA. 2009 Jul 15;302(3):306-14. doi: 10.1001/jama.2009.1018.
- Verleden GM, Vanaudenaerde BM, Dupont LJ, Van Raemdonck DE. Azithromycin reduces airway neutrophilia and interleukin-8 in patients with bronchiolitis obliterans syndrome. Am J Respir Crit Care Med. 2006 Sep 1;174(5):566-70. doi: 10.1164/rccm.200601-071OC. Epub 2006 Jun 1.
- Afessa B, Litzow MR, Tefferi A. Bronchiolitis obliterans and other late onset non-infectious pulmonary complications in hematopoietic stem cell transplantation. Bone Marrow Transplant. 2001 Sep;28(5):425-34. doi: 10.1038/sj.bmt.1703142.
- Dudek AZ, Mahaseth H, DeFor TE, Weisdorf DJ. Bronchiolitis obliterans in chronic graft-versus-host disease: analysis of risk factors and treatment outcomes. Biol Blood Marrow Transplant. 2003 Oct;9(10):657-66. doi: 10.1016/s1083-8791(03)00242-8.
- Vos R, Vanaudenaerde BM, Verleden SE, De Vleeschauwer SI, Willems-Widyastuti A, Van Raemdonck DE, Schoonis A, Nawrot TS, Dupont LJ, Verleden GM. A randomised controlled trial of azithromycin to prevent chronic rejection after lung transplantation. Eur Respir J. 2011 Jan;37(1):164-72. doi: 10.1183/09031936.00068310. Epub 2010 Jun 18.
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
August 1, 2011
Primary Completion (Actual)
July 8, 2016
Study Completion (Actual)
July 8, 2016
Study Registration Dates
First Submitted
August 16, 2011
First Submitted That Met QC Criteria
August 17, 2011
First Posted (Estimate)
August 19, 2011
Study Record Updates
Last Update Posted (Actual)
February 27, 2017
Last Update Submitted That Met QC Criteria
February 24, 2017
Last Verified
October 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011H0214
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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