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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 (HARBOR)

NCT05635136 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 16

Last updated 2024-01-03

No results posted yet for this study

Summary

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.

Conditions

  • Tomography, Optical Coherence
  • Kidney Transplantation

Interventions

OTHER

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

Sponsors & Collaborators

  • Centre Hospitalier Universitaire Dijon

    collaborator OTHER

  • Hôpital Necker-Enfants Malades

    collaborator OTHER

  • Centre Hospitalier William Morey - Chalon sur Saône

    lead OTHER

Principal Investigators

  • Dany Anglicheau · Hôpital Necker-Enfants Malades

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2022-04-30
Completion
2023-04-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05635136 on ClinicalTrials.gov