CompletedNot Applicable

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

2,410 participantsStarted 2004-01-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult kidney transplant recipient, defined as age 18 years or older at transplantation * Post-transplant kidney allograft biopsy * Archived FFPE kidney allograft biopsy tissue is available and suitable for transcriptomic profiling * Biopsy submitted for B-HOT nCounter transcriptomic profiling * Available Banff reference pathology diagnosis * Available Banff lesion information required for endpoint definition * Sample meeting prespecified nCounter assay quality-control criteria Exclusion Criteria: * Recipient age \<18 years at transplantation * Multi-organ transplantation * Pre-transplant biopsy * Missing Banff reference pathology diagnosis * Failure of prespecified nCounter quality-control criteria * Missing or insufficient data required to define the relevant reference endpoint

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Discrimination of molecular diagnostic classifiers (AUROC)

Timeframe: At baseline defined by kidney allograft biopsy (single time-point assessment).

Calibration of molecular diagnostic classifiers (Brier score, log loss)

Timeframe: At baseline defined by kidney allograft biopsy (single time-point assessment).

Trial details

NCT IDNCT07700563

SponsorParis Translational Research Center for Organ Transplantation

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-05-15

View on ClinicalTrials.gov More Kidney Transplant trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Discrimination of molecular diagnostic classifiers (AUROC)

Timeframe: At baseline defined by kidney allograft biopsy (single time-point assessment).

Calibration of molecular diagnostic classifiers (Brier score, log loss)

Timeframe: At baseline defined by kidney allograft biopsy (single time-point assessment).