Clinical trial NCT05635136: Histopathological Analysis of Renal Biopsies With Dynamic Full-field Optical Coherence Tomography, a Comparison to Conventional Histopathological Findings in Kidney Transplant Recipients (HARBOR)
Official title: Histopathological Analysis of Renal Biopsies With Dynamic Full-field Optical Coherence Tomography, a Comparison to Conventional Histopathological Findings in Kidney Transplant Recipients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tomography, Optical Coherence
Kidney Transplantation
Keywords: Kidney Transplantation
Kidney Biopsy
Full-field Optical Coherence Tomography
Lead sponsor: Centre Hospitalier William Morey - Chalon sur Saône
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire Dijon
name: Hôpital Necker-Enfants Malades
First posted: 2022-12-02
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient \> 18 years of age who received renal transplant are registered in the DIVAT cohort. 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 (Commission Nationale de l'Informatique et des Libertés)

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Banff lesion scores based on dynamic full-field optical coherence tomography measurement
timeFrame: Outcome measure is assessed 15 days following kidney transplant biopsy
Secondary outcomes:
measure: Banff diagnostic categories based on dynamic full-field optical coherence tomography measurement
timeFrame: Outcome measure is assessed 15 days following kidney transplant biopsy
Other outcomes:
Locations:
city: Chalon sur Saône
country: France
facility: Centre Hospitalier William Morey - Chalon sur Saône
state: Saône-et-Loire
Study officials:
affiliation: Hôpital Necker-Enfants Malades
name: Dany Anglicheau
role: PRINCIPAL_INVESTIGATOR
References:
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