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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) (HARBOR)

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ClinicalTrials.gov Identifier: NCT05635136
Recruitment Status : Active, not recruiting
First Posted : December 2, 2022
Last Update Posted : December 5, 2022
Sponsor:
Collaborators:
Centre Hospitalier Universitaire Dijon
Hôpital Necker-Enfants Malades
Information provided by (Responsible Party):
Centre Hospitalier William Morey - Chalon sur Saône

Study Description
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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.

Condition or disease Intervention/treatment
Tomography, Optical Coherence Kidney Transplantation Other: Dynamic full-field optical coherence tomography analysis of kidney transplant biopsy

Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 16 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Histopathological Analysis of Renal Biopsies With Dynamic Full-field Optical Coherence Tomography, a Comparison to Conventional Histopathological Findings in Kidney Transplant Recipients
Actual Study Start Date : February 1, 2022
Actual Primary Completion Date : April 30, 2022
Estimated Study Completion Date : April 30, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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")
 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


Outcome Measures
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Primary Outcome Measures :
  1. Banff lesion scores based on dynamic full-field optical coherence tomography measurement [ Time Frame: Outcome measure is assessed 15 days following kidney transplant biopsy ]

    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



Secondary Outcome Measures :
  1. Banff diagnostic categories based on dynamic full-field optical coherence tomography measurement [ Time Frame: Outcome measure is assessed 15 days following kidney transplant biopsy ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05635136


Locations
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France
Centre Hospitalier William Morey - Chalon sur Saône
Chalon sur Saône, Saône-et-Loire, France, 71100
Sponsors and Collaborators
Centre Hospitalier William Morey - Chalon sur Saône
Centre Hospitalier Universitaire Dijon
Hôpital Necker-Enfants Malades
Investigators
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Principal Investigator: Dany Anglicheau Hôpital Necker-Enfants Malades
More Information
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Publications:

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Responsible Party: Centre Hospitalier William Morey - Chalon sur Saône
ClinicalTrials.gov Identifier: NCT05635136    
Other Study ID Numbers: HARBOR
First Posted: December 2, 2022    Key Record Dates
Last Update Posted: December 5, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier William Morey - Chalon sur Saône:
Kidney Transplantation
Kidney Biopsy
Full-field Optical Coherence Tomography