Histopathological Analysis of Renal Biopsies With Dynamic Full-field Optical Coherence Tomography, a Comparison to Conventional Histopathological Findings in Kidney Transplant Recipients (HARBOR)

Study Overview
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Brief Summary
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Banff classification stands as gold standard and international consensus for the identification, diagnosis and categorization of renal allograft pathology. In addition to multiple revision dedicated to the clarification and refinement of these diagnostic categories, a special attention is now dedicated to the development of automated protocols serving the use of artificial intelligence in digital pathology. To be integrated in the actual early post-transplant monitoring procedure, such original approach is considered to match various growing expectations of clinicians and pathologists regarding the future of transplant nephropathology : decrease inter-observer variability, reduce human errors and limit time-consuming analysis of kidney biopsy. Among these, an accelerated reading and access to Banff diagnostic criteria could help initiating both appropriate and immediate treatment to improve graft survival in kidney transplant recipients. Yet conventional histopathology still requires the preparation of a paraffin block, sections as well as subsequent colorations that altogether delay the final pathological diagnosis and urge the need for additional diagnostic modalities. Designed to overcome this critical limitation, the HARBOR study intends to test the performance of direct histopathological examination of fresh kidney biopsy with full-field optical coherence tomography for the identification of Banff elemental lesions and diagnostic categories.

Official Title
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Histopathological Analysis of Renal Biopsies With Dynamic Full-field Optical Coherence Tomography, a Comparison to Conventional Histopathological Findings in Kidney Transplant Recipients

Conditions
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Tomography, Optical Coherence, Kidney Transplantation

Intervention / Treatment
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* Other: Dynamic full-field optical coherence tomography analysis of kidney transplant biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient > 18 years of age who received renal transplant registered in the DIVAT cohort with kidney biopsy between start study date and primary completion date Exclusion Criteria: inability to perform dynamic full-field optical coherence tomography observation at the moment of kidney biopsy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| The DIVAT cohort<br>patient > 18 years of age who received renal transplant are registered in the DIVAT cohort (standing for computerized and validated data in transplantation, Données Informatisées VAlidées Transplantation). It comprises more than 300 clinical and biological parameters collected at the time of transplant, at 3 months, 6 months and at each anniversary of the transplant. The DIVAT cohort and network is accredited by the CNIL (standing for Commission Nationale de l'Informatique et des Libertés) | Other: Dynamic full-field optical coherence tomography analysis of kidney transplant biopsy<br>* Dynamic full-field optical coherence tomography analysis of kidney transplant biopsy before conventional histopathological analysis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Banff lesion scores based on dynamic full-field optical coherence tomography measurement | Provide a better understanding of the ability of dynamic full-field optical coherence tomography to identify and score the usual Banff lesions comprising interstitial inflammation, tubulitis, intimal arteritis, glomerulitis, peritubular capillaritis, interstitial fibrosis, tubular atrophy, vascular fibrous intimal thickening, glomerular basement membrane double contours, mesangial matrix expansion, arteriolar hyalinosis, hyaline arteriolar thickening, total inflammation and inflammation in the area of both interstitial fibrosis and tubular atrophy. Note that the the Banff scoring system has three grades for each lesion : from mild (1) to moderate (2) and severe (3). In each case, the higher the score the worse the outcome, according to the 2018 Reference Guide to the Banff Classification of Renal Allograft Pathology | Outcome measure is assessed 15 days following kidney transplant biopsy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Banff diagnostic categories based on dynamic full-field optical coherence tomography measurement | Provide a better understanding of the ability of dynamic full-field optical coherence tomography to identify the usual Banff diagnostic categories comprising normal biopsy (or biopsy with nonspecific changes), biopsy with antibody-mediated changes, biopsy considered borderline or suspicious for acute T cell-mediated rejection, biopsy with T cell-mediated rejection, biopsy with both interstitial fibrosis and tubular atrophy, biopsy with changes not considered to be caused by acute or chronic rejection Note that the Banff Diagnostic Categories form the core of the Banff Classification of Renal Allograft Pathology according the 2018 Reference Guide to the Banff Classification of Renal Allograft Pathology | Outcome measure is assessed 15 days following kidney transplant biopsy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kidney Transplantation, Kidney Biopsy, Full-field Optical Coherence Tomography