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Clinical Trials/NCT05728216
NCT05728216RecruitingNot Applicable

Histopathological Analysis of Renal Biopsies With Dynamic Full-field Optical Coherence Tomography, a Comparison to Conventional Histopathological Findings for the Diagnosis of Either Acute Kidney Injury or Chronic Kidney Disease in Routine Practices

Centre Hospitalier William Morey - Chalon sur Saône1 site in 1 country50 target enrollmentStarted: November 1, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
50
Locations
1
Primary Endpoint
Histopathological analysis of elementary lesions in nephropathology with dynamic full-field optical coherence tomography

Study Overview

Brief Summary

Kidney biopsy play a key role for the investigation of either acute kidney injury or chronic kidney disease. Despite possible complications due to the invasive nature of the biopsy, such procedure is still essential in a number of clinical situations to improve the diagnosis specificity of kidney disease, better inform about its prognosis and guide the management of a future treatment. Pursuing the idea to improve both performance and rapidity associated with the histopathological analysis of kidney biopsy, with a possible recourse to artificial intelligence-based renal pathology, the present study intends to assess the impact of direct histopathological examination of kidney biopsy with dynamic full-field optical coherence tomography in routine practices for the diagnosis of either acute kidney injury or chronic kidney disease.

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • patients > 18 years of age with suspected acute kidney injury requiring biopsy in the nephrology department
  • patients > 18 years of age with suspected chronic kidney disease requiring biopsy in the nephrology department

Exclusion Criteria

  • inability to perform dynamic full-field optical coherence tomography observation at the moment of kidney biopsy

Arms & Interventions

NEPHROCT cohort

Patients > 18 years of age with suspected acute kidney injury or chronic kidney disease requiring biopsy in the nephrology department

Intervention: Dynamic full-field optical coherence tomography analysis of kidney biopsy (Other)

Outcomes

Primary Outcomes

Histopathological analysis of elementary lesions in nephropathology with dynamic full-field optical coherence tomography

Time Frame: Outcome measure is assessed 15 days following kidney biopsy

Provide a better understanding of the ability of dynamic full-field optical coherence tomography to identify and characterize common glomerular (abnormal / double contour of the glomerular basement membrane, focal segmental glomerulosclerosis, collapse of the glomerular tuft, proliferation of glomerular epithelial cells, endocapillary proliferation, mesangial expansion, necrosis and proliferation with mild increase in extracapillary cells...), vascular (hyaline change, fibrinoid change / necrosis, thrombosis, inflammation or necrosis of vascular walls, arteriosclerosis) and tubulointerstitial (acute tubular necrosis, cytoplasmic vacuolization, lipid inclusions in proximal / distal tubular cells, atrophy of tubules, edema, inflammation or interstitial fibrosis, cortical necrosis) lesions seen in kidney biopsy

Secondary Outcomes

  • Histopathological analysis of healthy kidney biopsy with dynamic full-field optical coherence tomography(Outcome measure is assessed 15 days following kidney biopsy)

Investigators

Sponsor
Centre Hospitalier William Morey - Chalon sur Saône
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Thomas Maldiney

Principal Investigator

Centre Hospitalier William Morey - Chalon sur Saône

Study Sites (1)

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