NCT02836938

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 5, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 19, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

February 14, 2017

Status Verified

February 1, 2017

Enrollment Period

6 months

First QC Date

July 5, 2016

Last Update Submit

February 13, 2017

Conditions

Chronic Lung Allograft Dysfunction (CLAD)

Outcome Measures

Primary Outcomes (1)

  • Concentration of exhaled breath volatile organic compounds

    one sample will be collected between 6 month and 20 years after lung transplantation

Study Arms (3)

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

Interventions

Collection of exhaled breath volatile organic compoundsOTHER
ControlMildSevere

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Group of transplant patients with and without signs of BOS

You may qualify if:

  • Outpatient bilateral lung transplant recipients including combined transplants

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hannover Medical School

Hanover, 30625, Germany

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

July 5, 2016

First Posted

July 19, 2016

Study Start

June 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

February 14, 2017

Record last verified: 2017-02

Locations

DE(1)