CLAD: Finding Biomarkers to Predict Rejection and/ or Outcome After Lung Transplantation

Terminated

• Conditions: Primary Graft Dysfunction; Lung Transplant Failure and Rejection
• Interventions: Other: blood and exhaled breath specimens

• Registration Number: NCT04558333
• Lead Sponsor: University Hospital, Antwerp

Brief Summary

Lung transplantation is the ultimate treatment for end stage lung diseases. Survival after lung transplantation is limited mainly due to the development of chronic allograft dysfunction (CLAD). Both acute cellular rejection and primary grade dysfunction (PGD) have been associated with the development of CLAD. In this study we will investigate multiple prognostic factors that influence long term survival after lung transplantation with a specific interest in PGD, acute rejection and the development of CLAD.

Detailed Description

At specific time points (according to protocol) exhaled breath, blood specimens, bronchoalveolar lavage and biopsies will be collected. These will be analyzed in an attempt to identify possible biomarkers that will predict the development of PGD and/or CLAD.

Study Timeline

• Study Start: 2019-10-28
• Study First Submitted: 2020-09-09
• Study First Submitted QC: 2020-09-15
• Study First Posted: 2020-09-22
• Primary Completion: 2024-02-28
• Study Completion: 2024-02-28
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-02
• Last Update Posted: 2024-05-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• all lung transplant recipients > 18 years signed ICF (informed consent form)

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
LTx (lung transplant) patients	blood and exhaled breath specimens	identification of possible biomarkers

Primary Outcome Measures

Name	Time	Method
identify prognostic biomarkers in blood, bronchoalveolar lavage and exhaled breath that will determine long term survival after human lung transplantation.	up to 520 weeks	death

Secondary Outcome Measures

Name	Time	Method
Secondary objectives are obtaining information on the development of (Primary graft development) PGD in relationship to respiratory viruses, genetic profile and exhaled breath in patients and (if possible donors) after human lung transplantation.	from transplantation till 72 hours after surgery	PGD

Trial Locations

Locations (1)

University Hospital Antwerp; 🇧🇪 Edegem, Antwerp, Belgium