Characterization of Bronchiolitis-obliterans Syndrome (BOS) Following Lung Transplantation

NCT00774449 | Unknown DMC

• 1 other identifier: 5108
• Study Type: observational
• Target: 261
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic organ dysfunction after lung transplantation (BOS) is the most common cause of death in long-term survivors after lung transplantation and refractory to most interventions. Early markers will be established in this project study to overcome the problem of disease recognition when impairment of graft function is already taken place. Long-term longitudinal monitoring in stable recipients of innovative markers of airway inflammation and ventilation and new imaging techniques will define different entities of chronic organ dysfunction after LTx. A database and specimen service unit for further projects will be created. Hypothesis: This project will reveal new markers and imaging tools in recipients who develop BOS after lung transplantation. These tools will allow earlier diagnosis and more accurate monitoring of the disease process. Different patterns of the disease will be characterized.

Conditions

Lung Transplantation; Bronchiolitis Obliterans Syndrome

Keywords

lung transplantation; bronchiolitis obliterans syndrome; broncholaveolar lavage; high-resolution computertomography; quality of life

Outcome Measures

Primary Outcomes (1)

• Bronchiolitis obliterans Syndrom (BOS)

  5 years

Study Arms (1)

1

individuals, who have undergone double (DLTx) or heart and lung transplantation (HLTx) at Hannover Medical School 6 months prior to inclusion

Eligibility Criteria

• Age: 18 Years - 68 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

individuals, who have undergone double (DLTx) or heart and lung transplantation (HLTx) at Hannover Medical School 6 months prior to inclusion

You may qualify if:

• Ages: 18 to 68 Years
• Gender: both
• Stable graft function (FEV1 \>90% baseline)

You may not qualify if:

• Severe airway complications after surgery necessitating repeated intervention during the last 3 months
• Single lung (SLTx) and living lobar recipients
• Inability to undergo bodyphlethysmography e.g. due to persistent infection with multi-drug resistant bacteria (MRSA, VRE, Burkholderia Cepacia, Pandorea)

Sponsors & Collaborators

• Hannover Medical School: lead

Study Sites (1)

Department of Respiratory Medicine, Medizinische Hochschule Hannover

Hanover, 30625, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

bronchoalveolar lavage, transbronchial biopsies, blood samples

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

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

• Jens Gottlieb, MD

  Hannover Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jens Gottlieb, MD

CONTACT

+49-511-532; gottlieb.jens@mh-hannover.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 16, 2008
• First Posted: October 17, 2008
• Study Start: July 1, 2009
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: July 21, 2011

Record last verified: 2009-07

Locations

DE (1)