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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-01

Study Completion Date

2023-04-30

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.

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Detailed Description

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Conditions

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Tomography, Optical Coherence Kidney Transplantation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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The DIVAT cohort

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")

Dynamic full-field optical coherence tomography analysis of kidney transplant biopsy

Intervention Type OTHER

Dynamic full-field optical coherence tomography analysis of kidney transplant biopsy before conventional histopathological analysis

Interventions

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Dynamic full-field optical coherence tomography analysis of kidney transplant biopsy

Dynamic full-field optical coherence tomography analysis of kidney transplant biopsy before conventional histopathological analysis

Intervention Type OTHER

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