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

NCT06436027 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 496

Last updated 2024-05-30

No results posted yet for this study

Summary

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).

Conditions

  • Heart Transplant Rejection

Interventions

DIAGNOSTIC_TEST

Nano-Heart tool: Intra-Graft Targeted Gene Expression Profiling

Targeted molecular profiling will be performed on formalin-fixed paraffin-embedded (FFPE) endomyocardial biopsies using the NanoString nCounter technology. A consortium-approved consensual targeted panel including 770 genes, developed by the Banff Molecular Diagnostics Working Group (MDWG) will be used.

Sponsors & Collaborators

  • Cedars Sinai Medical Center, Los Angeles, USA

    collaborator UNKNOWN

  • University of Padova

    collaborator OTHER

  • Paris Translational Research Center for Organ Transplantation

    lead OTHER

Principal Investigators

  • Alexandre Loupy, MD, PhD · Paris Translational Research Center for Organ Transplantation

  • Guillaume Coutance, MD, PhD · Paris Translational Research Center for Organ Transplantation

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-10
Primary Completion
2023-12-15
Completion
2023-12-15

Countries

  • United States
  • France
  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06436027 on ClinicalTrials.gov