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

NCT04558333 | Terminated

• 1 other identifier: CLAD
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Transplant Failure and Rejection; Primary Graft Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

LTx (lung transplant) patients

identification of possible biomarkers

Other: blood and exhaled breath specimens

Interventions

blood and exhaled breath specimens OTHER

identification of possible biomarkers

LTx (lung transplant) patients

Eligibility Criteria

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

Study Population

all lung transplant recipients

You may qualify if:

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

You may not qualify if:

• none

Sponsors & Collaborators

• University Hospital, Antwerp: lead

Study Sites (1)

University Hospital Antwerp

Edegem, Antwerp, 2650, Belgium

Location

Biospecimen

Retention: SAMPLES WITH DNA

the first 72 hours after transplantation cell free DNA will be collected

MeSH Terms

Conditions

Rejection, Psychology; Primary Graft Dysfunction

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Social Behavior; Behavior; Reperfusion Injury; Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Thérèse Lapperre, MD

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Lapperre

Study Record Dates

• First Submitted: September 9, 2020
• First Posted: September 22, 2020
• Study Start: October 28, 2019
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: May 3, 2024

Record last verified: 2024-05

Locations

BE (1)