NCT07700563Completed
Development and Validation of HistoMX, a Gene-Expression Platform for Molecular Interpretation of Kidney Allograft Biopsies
An Automated Gene Expression-Based Platform for Multidimensional Assessment and Interpretation of Kidney Allograft Biopsies: Development and Multicenter External Validation (HistoMX)
Source: ClinicalTrials.gov · Last updated 14 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 2410 (actual)
- First submitted
- 24 Jun 2026
- Start date
- 1 Jan 2004
- Primary completion date
- 15 May 2026
- Lead sponsor
- Paris Translational Research Center for Organ Transplantation
- Diseases
- Chronic kidney disease
- NCT number
- NCT07700563
What you commit to
- Study type: Observational
- Participants enrolled: 2410
- From 1 Jan 2004 to the primary completion date, 15 May 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Multi-organ transplantation
- Pre-transplant biopsy
Other illness
- Failure of prespecified nCounter quality-control criteria
Age
- Recipient age \<18 years at transplantation
Other
- Missing Banff reference pathology diagnosis
- Missing or insufficient data required to define the relevant reference endpoint
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.