Study on Systemic and Airway Biomarkers in Haemopoietic Stem Cell Transplantation

NCT00956358 | Completed

• 1 other identifier: UW 09-107
• Study Type: observational
• Target: 228
• Locations: 1 country
• Sites: 1

Brief Summary

Haemopoietic stem cell transplantation (HSCT) has become a major life-saving treatment for many haematological conditions, mostly malignancies. However, there are lots of potential complications that hinder the long-term success of HSCT, in which bronchiolitis obliterans syndrome (BOS) is one of such serious complications. Basically, BOS represents a form of graft-versus-host immunological damage of small airways (bronchioles), leading to progressive narrowing of small airways and thus obstructive lung function abnormalities. With progressive loss of lung function in BOS, patients after HSCT can be complicated by intractable respiratory failure that results in mortality. Up until now, there is still no reliable way to accurately predict or detect BOS early to allow pharmacological interventions. Therefore there is intense interest in the search for biomarkers that can help to predict the occurrence of BOS after HSCT. Apart from biomarkers (e.g., cytokines) in blood, there has been recent development in the sampling of airway lining fluid by a non-invasive method, i.e., collection of exhaled breath condensate (EBC). In airway diseases such as asthma or chronic obstructive pulmonary disease, EBC has been found to have various cytokines which can serve as potential biomarkers of disease activity. Since BOS is largely a small airway disease, it becomes logical to investigate the profile of biomarkers in EBC as predictors for BOS after HSCT. Therefore this study has been designed to look into the role of biomarkers in blood and EBC in early detection of BOS after HSCT.

Conditions

Hematological Diseases

Keywords

bronchiolitis obliterans syndrome

Outcome Measures

Primary Outcomes (1)

• Lung function indices

  Every 3 months until either 18 months post-HSCT or diagnosis of BOS

Study Arms (3)

Pre-HSCT

Haematological conditions requiring haemopoietic stem cell transplantation

Post-HSCT with BOS

Occurence of bronchiolitis obliterans syndrome after haemopoietic stem cell transplantation

Control

Healthy HSCT donors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Haematological conditions requiring HSCT and healthy HSCT donors will be identified from Bone Marrow Transplatation (BMT) Unit and post-HSCT patients with BOS will be identified from Respiratory Medicine clinics at Queen Mary Hospital.

You may qualify if:

• Haematological conditions requiring HSCT (either autologous or allogeneic with sibling donor), post-HSCT BOS, or healthy HSCT donors
• Life expectancy \> 12 weeks

You may not qualify if:

• Respiratory failure requiring use of supplemental oxygen therapy
• Known airway diseases including asthma, chronic obstructive pulmonary disease and bronchiectasis

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma, buffy coat, red blood cell and exhaled breath condensate samples.

MeSH Terms

Conditions

Hematologic Diseases; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Officials

• Chung-man James Ho

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: August 9, 2009
• First Posted: August 11, 2009
• Study Start: March 1, 2009
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 12, 2016

Record last verified: 2016-05

Locations

HK (1)