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Development and Validation of HistoMX, a Gene-Expression Platform for Molecular Interpretation of Kidney Allograft Biopsies

NCT07700563 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2410

Last updated 2026-07-14

No results posted yet for this study

Summary

This retrospective multicentre observational study developed and validated HistoMX, an automated gene-expression-based platform for multidimensional molecular interpretation of kidney allograft biopsies.

The study included 2,410 archived post-transplant kidney allograft biopsy samples from adult kidney transplant recipients. Formalin-fixed paraffin-embedded biopsy tissue was profiled using the Banff Human Organ Transplant panel on the NanoString nCounter platform. HistoMX integrates locked preprocessing, quality control, single-sample normalization, diagnostic classification, Banff lesion-level modelling, molecular lesion-severity scores, composite injury indices, immune-cell estimation, pathway-enrichment analysis, and automated clinician-facing reporting.

The platform was evaluated against reference histology based on the Banff classification. HistoMX was designed to complement, not replace, conventional histopathology by providing standardized molecular evidence across diagnostic, lesion-level, continuous injury, and biological dimensions of kidney allograft injury.

Conditions

  • Kidney Transplant
  • Rejection of Renal Transplant
  • Antibody Mediated Rejection
  • BK Virus Nephropathy
  • T-Cell Mediated Rejection
  • Chronic Kidney Disease (CKD) Stage 5
  • Kidney Allograft Injury

Sponsors & Collaborators

  • OrganX

    collaborator UNKNOWN

  • Université Paris Cité

    collaborator OTHER

  • CareDx

    collaborator INDUSTRY

  • Arkana Labs

    collaborator UNKNOWN

  • Cedars-Sinai Medical Center

    collaborator OTHER

  • Massachusetts General Hospital

    collaborator OTHER

  • University of Alberta

    collaborator OTHER

  • Paris Translational Research Center for Organ Transplantation

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-01-01
Primary Completion
2026-05-15
Completion
2026-05-15

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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 NCT07700563 on ClinicalTrials.gov