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
  Purpose

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
Lung Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pulmonary Complications of Hematopoietic Stem Cell Transplantation

Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 1b) To identify the mechanisms by which CD8+ regulatory cells suppress the alloimmune response. [ Time Frame: end of study ] [ Designated as safety issue: No ]

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.


Estimated Enrollment: 350
Study Start Date: October 2005
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
lung disease
hematopoietic stem cell transplantation (HSCT)

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).

  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

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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00837681

Contacts
Contact: Karen Wood, MD 614-293-4978 karen.wood@osu.edu
Contact: Janice Drake, CRTT 614-293-4978 janice.drake@osumc.edu

Locations
United States, Ohio
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Janice Drake, CRTT    614-293-4978    janice.drake@osumc.edu   
Contact: Anita Kapil    614-293-4978    Anita.Kapil@osumc.edu   
Sponsors and Collaborators
Karen Wood
Investigators
Principal Investigator: Karen Wood, MD Ohio State University
  More Information

No publications provided

Responsible Party: Karen Wood, Karen Wood M.D., The Ohio State University
ClinicalTrials.gov Identifier: NCT00837681     History of Changes
Other Study ID Numbers: 2005C0058
Study First Received: February 4, 2009
Last Updated: June 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University:
Bone Marrow Transplant
hematopoietic stem cell transplantation

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 16, 2014