Trial · NCT07700563
Development and Validation of HistoMX, a Gene-Expression Platform for Molecular Interpretation of Kidney Allograft Biopsies
NCT07700563, Completed, Paris Translational Research Center for Organ Transplantation
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Development and Validation of HistoMX, a Gene-Expression Platform for Molecular Interpretation of Kidney Allograft Biopsies. Trials, record NCT07700563. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07700563
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Development and Validation of HistoMX, a Gene-Expression Platform for Molecular Interpretation of Kidney Allograft Biopsies
- NCT number
- NCT07700563
- Status
- Completed
- Enrollment
- 2,410 participants, actual
- Lead sponsor
- Paris Translational Research Center for Organ Transplantation
- 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
- First posted
- 2026-07-14
- Last updated
- 2026-07-14
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Discrimination of molecular diagnostic classifiers (AUROC) | At baseline defined by kidney allograft biopsy (single time-point assessment). | Area under the ROC curve for prediction of each main diagnostic category (antibody-mediated rejection, T cell-mediated rejection, any rejection, BK virus nephropathy, acute tubular injury without rejection, no-active-inflammatory complication) versus the Banff reference histological diagnosis, in internal and external validation cohorts. |
| Primary | Calibration of molecular diagnostic classifiers (Brier score, log loss) | At baseline defined by kidney allograft biopsy (single time-point assessment). | Calibration of predicted diagnostic probabilities for each main diagnostic endpoint, assessed using calibration plots, calibration intercept and slope, Brier score, and log loss, compared with the Banff reference histological diagnosis. |
| Secondary | Precision-recall performance (AUPRC) of molecular diagnostic classifiers | At baseline defined by kidney allograft biopsy (single time-point assessment). | Area under Precision-recall curve (AUPRC) for each diagnostic endpoint, including antibody-mediated rejection, T cell-mediated rejection, any rejection, BK virus nephropathy, acute tubular injury without rejection, and no active inflammatory complication. |
| Secondary | Discrimination of Banff lesion classifiers (AUROC) for binary lesion. | At baseline defined by kidney allograft biopsy (single time-point assessment). | Discrimination of Banff lesion classifiers (AUROC) for binary lesion presence including glomerulitis (g), peritubular capillaritis (ptc), microvascular inflammation (mvi), interstitial inflammation (i), tubulitis (t), intimal arteritis (v), transplant glomerulopathy (cg), interstitial fibrosis (ci), tubular atrophy (ct), vascular fibrous intimal thickening (cv), and interstitial fibrosis/tubular atrophy. (IFTA). |
| Secondary | Correlation of continuous molecular lesion-severity scores with histological Banff grades. | At baseline defined by kidney allograft biopsy (single time-point assessment). | Correlation and concordance between continuous molecular lesion-severity scores derived from ordinal classifiers and histological Banff lesion grades, assessed using Spearman correlation, Pearson correlation, concordance index, and related calibration approaches. |
| Secondary | Performance of composite molecular injury indices (AMR/MVI, TCMR/TI, activity, chronicity). | At baseline defined by kidney allograft biopsy (single time-point assessment). | Performance of composite molecular injury indices (AMR/MVI, TCMR/TI, activity, chronicity) assessed by correlation with corresponding histological indices and, where appropriate, binary discrimination using area under the receiver-operating characteristic curve. |
| Secondary | Validation of cell-deconvolution estimates | At baseline defined by kidney allograft biopsy (single time-point assessment). | Correlation between HistoMX transcriptomic immune-cell estimates and multiplex immunofluorescence-derived tissue cell densities in an independent paired immunophenotyping subset of 32 patients contributing to 32 biopsies, focusing on T cells and macrophages. |
| Secondary | Concordance between molecular and histological diagnoses | At baseline defined by kidney allograft biopsy (single time-point assessment). | Proportion of histology-defined antibody-mediated rejection, T cell-mediated rejection, and any-rejection biopsies classified concordantly by HistoMX, with characterization of molecular-histological discordant biopsies. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07700563
GET https://conductscience.org/api/trials/v1/NCT07700563/registered