Breath Volatile Organic Compounds Patterns of Lung Transplant Patients With Chronic Lung Allograft Dysfunction

February 13, 2017 updated by: Prof. Dr. Jens Hohlfeld
It's the aim of this study to clarify, whether the non-invasive assessment of breath can serve as a novel clinical tool to assist in the diagnosis of CLAD. If different stages of BOS can be discriminated by the level of certain VOCs than there would also be a potential to actually predict the development at an early stage and would enable an earlier intervention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hannover, Germany, 30625
        • Hannover Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Group of transplant patients with and without signs of BOS

Description

Inclusion Criteria:

  • Outpatient bilateral lung transplant recipients including combined transplants

Exclusion Criteria:

  • Active Smoking Oxygen therapy Infection with multi or pan-resistant bacteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Severe
Severe chronic lung allograft dysfunction (CLAD), bronchiolitis obliterans syndrome (BOS), stage 3
Other: Collection of exhaled breath volatile organic compounds
Mild
Mild chronic lung allograft dysfunction (CLAD), bronchiolitis obliterans syndrome (BOS), stage 1-2
Other: Collection of exhaled breath volatile organic compounds
Control
Bronchiolitis obliterans syndrome (BOS), stage 0
Other: Collection of exhaled breath volatile organic compounds

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Concentration of exhaled breath volatile organic compounds
Time Frame: one sample will be collected between 6 month and 20 years after lung transplantation
one sample will be collected between 6 month and 20 years after lung transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof. Dr. Jens Hohlfeld

Collaborators

Hannover Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

July 5, 2016

First Submitted That Met QC Criteria

July 14, 2016

First Posted (Estimate)

July 19, 2016

Study Record Updates

Last Update Posted (Actual)

February 14, 2017

Last Update Submitted That Met QC Criteria

February 13, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • TXVOC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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