Pulmonary Disease in Patients Undergoing Hematopoietic Stem Cell Transplantation

This study is enrolling participants by invitation only.

Sponsor:

Information provided by (Responsible Party):

Karen Wood, The Ohio State University

ClinicalTrials.gov Identifier:

NCT01420172

First received: August 16, 2011

Last updated: October 31, 2012

Last verified: October 2012

History of Changes

Purpose

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.

Condition	Intervention
Post Hematopoietic Stem Cell Transplantation	Other: Data Collection

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Retrospective
Official Title:	Pulmonary Disease in Patients Undergoing Hematopoietic Stem Cell Transplantation.

Further study details as provided by Ohio State University:

Primary Outcome Measures:

A retrospective diagnostic review on pulmonary disease related to hematopoietic stem cell transplantation. [ Time Frame: Up to 15 years ] [ Designated as safety issue: No ]
To determine factors influencing pulmonary disease related to HSCT.

Secondary Outcome Measures:

A retrospective treatment review on treatment strategies for pulmonary disease related to hematopoietic stem cell transplantation. [ Time Frame: Up to 15 years ] [ Designated as safety issue: No ]
To review treatment strategies for pulmonary disease post transplant for effectiveness.

Estimated Enrollment:	2000
Study Start Date:	August 2011
Estimated Study Completion Date:	January 2014
Estimated Primary Completion Date:	January 2014 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Post hematopoietic stem cell transplantation Patients who were seen post hematopoietic stem cell transplantation between 01Jan2000 and 30Jun2011	Other: Data Collection Collection of data on patients who were seen at OSUMC at any time between 01Jan2000 and 30Jun2011 post hematopoietic stem cell transplantation

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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.

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01420172

Locations

United States, Ohio
The Ohio State University Medical Center
Columbus, Ohio, United States, 43221

Sponsors and Collaborators

Karen Wood

More Information

Publications:

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. Review.

Williams KM, Chien JW, Gladwin MT, Pavletic SZ. Bronchiolitis obliterans after allogeneic hematopoietic stem cell transplantation. JAMA. 2009 Jul 15;302(3):306-14.

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.

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. Epub 2006 Jun 1.

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. Epub 2010 Jun 18.

Responsible Party:	Karen Wood, MD, The Ohio State University
ClinicalTrials.gov Identifier:	NCT01420172 History of Changes
Other Study ID Numbers:	2011H0214
Study First Received:	August 16, 2011
Last Updated:	October 31, 2012
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 18, 2013

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