Molecular Diagnosis of Heart Allograft Rejection Using Intra-Graft Targeted Gene Expression Profiling.

Completed

Conditions studied: Heart Transplant Rejection

In brief

The goal of this observational study is to develop and validate a molecular heart rejection diagnostic system based on targeted transcriptome as a novel monitoring companion tool for heart allograft precision diagnostics applicable to formalin-fixed paraffin-embedded endomyocardial biopsies. The primary outcome will be the biopsy-proven rejection, that will be predicted with molecular classifiers (cellular and antibody-mediated rejection scores).

Key facts

Study ID

NCT06436027

Run by

Paris Translational Research Center for Organ Transplantation

People needed

496

Starts

2021-11-10

Expected to finish

2023-12-15

Last updated by the study team

2024-05-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• heart transplant recipients ≥ 18 years old
• at least one endomyocardial biopsy performed as part of routine clinical care
• biopsy performed at least ≥ 1 month post transplant and less that 10-year post-transplant
• written informed consent

You may not qualify if…

• age below 18 years old

Where it is running

• Cedars Sinai Medical Center — Los Angeles, California, United States
• Paris Translational Research Center for Organ Transplantation — Paris, France
• Center Gallucci of the University General Hospital of Padova — Padova, Italy

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.