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NCT06436027 · ClinicalTrials.gov registry record
Molecular Diagnosis of Heart Allograft Rejection Using Intra-Graft Targeted Gene Expression Profiling.
A clinical trial, sponsored by Paris Translational Research Center for Organ Transplantation.
- Completed
- Registry status
- 496
- Enrollment target
NCT06436027: Completed study, sponsored by Paris Translational Research Center for Organ Transplantation.
NCT06436027 is a clinical trial that has completed, run by Paris Translational Research Center for Organ Transplantation. The registered enrollment target is 496 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06436027 has completed, sponsored by Paris Translational Research Center for Organ Transplantation.
- COMPLETED
- Registry status
- 496 participants
- Enrollment target
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).
Primary Outcome
Prediction performances of the molecular classifiers (cellular and antibody-mediated rejection scores) to predict biopsy-proven rejection: diagnostic accuracy, Receiver Operating Characteristic - area under the curve, Precision Recall - area under the curve, Brier score, F1 score.
Interventions
- DIAGNOSTIC_TEST Nano-Heart tool: Intra-Graft Targeted Gene Expression Profiling
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 496 participants |
| Start Date | 2021-11-10 |
| Est. Completion | 2023-12-15 |
What the finished NCT06436027 record still lists
NCT06436027 is an observational study that tracks outcomes without assigning an intervention. The registered 496 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Nano-Heart tool: Intra-Graft Targeted Gene Expression Profiling is the first listed.
NCT06436027 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06436027 about?
NCT06436027 is a clinical study titled "Molecular Diagnosis of Heart Allograft Rejection Using Intra-Graft Targeted Gene Expression Profiling.". 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 pr...
What is the current status of trial NCT06436027?
This trial is currently completed. The enrollment target is 496 participants. The study started on 2021-11-10. Estimated completion is 2023-12-15.
What interventions are being tested in trial NCT06436027?
The interventions under investigation include: Nano-Heart tool: Intra-Graft Targeted Gene Expression Profiling (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT06436027?
This trial is sponsored by Paris Translational Research Center for Organ Transplantation, which has 7 total clinical trials registered on ClinicalTrials.gov.
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