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Pulmonary Complications of Hematopoietic Stem Cell Transplantation

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ClinicalTrials.gov Identifier: NCT00837681
Recruitment Status : Completed
First Posted : February 5, 2009
Last Update Posted : February 27, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to determine risk factors associated with the development of lung disease after hematopoietic stem cell transplantation. Depending on the results and findings of this study, it may be possible to predict who is at higher risk of serious complications and ultimately develop therapies to prevent or treat this lung disease.

Condition or disease
Lung Disease

Detailed Description:
The development of pulmonary complications after hematopoietic stem cell transplantation is responsible for significant morbidity and mortality. The incidence of pulmonary disease has been reported to be as high as 50% of all patients that undergo transplant. The most common manifestation of early onset lung disease is idiopathic pneumonia syndrome. This can occur in autologous and allogeneic transplants, with an incidence between 5% and 10% and a mortality rate as high as 74%(1). Late onset pulmonary disease may be even more frequent and has been reported between 10-24% in recipients of allogeneic HSCT(2-4). Additionally, a recent study demonstrated 26% of patients develop airflow obstruction after transplant and this was correlated with mortality(5). One quite useful classification system divides late onset pulmonary disease into bronchiolitis obliterans and interstitial pneumonia(4). Interstitial pneumonia is a condition characterized by diffuse infiltrates, often with lymphocyte predominance, and associated with restrictive defects on pulmonary function testing. Bronchiolitis obliterans is characterized by progressive airflow obstruction and a normal radiograph (except possibly associated air trapping). The incidence of bronchiolitis obliterans after HSCT varies widely, but is usually reported to be between 1% and 11%(6-8), although the presence of post HSCT obstructive airway disease was reported at 26% in a recent large study(5). Late onset pulmonary diseases are often treated with increased immunosuppression, but the prognosis is poor with limited response to therapy(9; 4).

Study Design

Study Type : Observational
Actual Enrollment : 350 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pulmonary Complications of Hematopoietic Stem Cell Transplantation
Study Start Date : October 2005
Primary Completion Date : July 8, 2016
Study Completion Date : July 8, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Diseases
U.S. FDA Resources

Groups and Cohorts

lung disease
hematopoietic stem cell transplantation (HSCT)

Outcome Measures

Primary Outcome Measures :
  1. To determine factors contributing to the development of lung disease after hematopoietic stem cell transplantation (HSCT [ Time Frame: end of study ]

Secondary Outcome Measures :
  1. 1b) To identify the mechanisms by which CD8+ regulatory cells suppress the alloimmune response. [ Time Frame: end of study ]

Biospecimen Retention:   Samples With DNA

Blood draw will be 10cc of blood, analysis includes % of CD8+CD57+ and CD8+CD28-. On one occasion, after the 6 mo. post transplant timepoint the subject will be asked to donate a larger amount of blood (50cc) if they are not anemic.

***Respiratory Specimens of extra BAL or biopsy specimens will be collected at any point a study patient undergoes a clinically warranted bronchoscopy or lung biopsy procedure and the diagnostic physician feels there is adequate specimen to use extra sample for research purposes.

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients scheduled to undergo hematopoietic stem cell transplantation (HSCT)

Inclusion Criteria:

1. All patients scheduled to undergo hematopoietic stem cell transplantation (HSCT)

Exclusion Criteria:

  1. Patients whose ability to give informed consent is in question.
  2. Pregnancy.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00837681

United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Karen Wood
Principal Investigator: Karen Wood, MD Ohio State University
More Information

Responsible Party: Karen Wood, Karen Wood M.D., The Ohio State University
ClinicalTrials.gov Identifier: NCT00837681     History of Changes
Other Study ID Numbers: 2005C0058
First Posted: February 5, 2009    Key Record Dates
Last Update Posted: February 27, 2017
Last Verified: July 2016

Keywords provided by Karen Wood, The Ohio State University:
Bone Marrow Transplant
hematopoietic stem cell transplantation

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases