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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00837681
Other study ID # 2005C0058
Secondary ID
Status Completed
Phase N/A
First received February 4, 2009
Last updated February 24, 2017
Start date October 2005
Est. completion date July 8, 2016

Study information

Verified date July 2016
Source Ohio State University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 350
Est. completion date July 8, 2016
Est. primary completion date July 8, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States The Ohio State University Columbus Ohio

Sponsors (1)

Lead Sponsor Collaborator
Karen Wood

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary To determine factors contributing to the development of lung disease after hematopoietic stem cell transplantation (HSCT end of study
Secondary 1b) To identify the mechanisms by which CD8+ regulatory cells suppress the alloimmune response. end of study
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