Pulmonary Complications of Hematopoietic Stem Cell Transplantation

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Ohio State University
Sponsor:
Information provided by (Responsible Party):
Karen Wood, The Ohio State University
ClinicalTrials.gov Identifier:
NCT00837681
First received: February 4, 2009
Last updated: June 30, 2014
Last verified: June 2014

February 4, 2009
June 30, 2014
October 2005
December 2016   (final data collection date for primary outcome measure)
To determine factors contributing to the development of lung disease after hematopoietic stem cell transplantation (HSCT [ Time Frame: end of study ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00837681 on ClinicalTrials.gov Archive Site
1b) To identify the mechanisms by which CD8+ regulatory cells suppress the alloimmune response. [ Time Frame: end of study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Pulmonary Complications of Hematopoietic Stem Cell Transplantation
Pulmonary Complications of Hematopoietic Stem Cell Transplantation

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.

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).

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

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.

Non-Probability Sample

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

Lung Disease
Not Provided
lung disease
hematopoietic stem cell transplantation (HSCT)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
350
December 2016
December 2016   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Karen Wood, MD 614-293-4978 karen.wood@osu.edu
Contact: Janice Drake, CRTT 614-293-4978 janice.drake@osumc.edu
United States
 
NCT00837681
2005C0058
Yes
Karen Wood, The Ohio State University
Karen Wood
Not Provided
Principal Investigator: Karen Wood, MD Ohio State University
Ohio State University
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP