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

Primary Graft Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04558333
• Other study ID #: CLAD
• Status: Recruiting
• Start date: October 28, 2019
• Est. completion date: October 2039

Study information

• Verified date: September 2020
• Source: University Hospital, Antwerp
• Contact: Johanna M Kwakkel-van Erp, MD, PhD
• Phone: 38215469
• Email: johanna.Kwakkel-vanErp[@]uza.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: October 2039
• Est. primary completion date: October 2039
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Lung Transplant Failure and Rejection
• Primary Graft Dysfunction

Intervention

Other:
• blood and exhaled breath specimens
identification of possible biomarkers

Locations

Country	Name	City	State
Belgium	University Hospital Antwerp	Edegem	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	identify prognostic biomarkers in blood, bronchoalveolar lavage and exhaled breath that will determine long term survival after human lung transplantation.	death	up to 520 weeks
Secondary	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.	PGD	from transplantation till 72 hours after surgery