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NCT Number: NCT05728216

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 (NEPHROCT)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier William Morey - Chalon sur Saône

Chalon-sur-Saône, Saône-et-Loire, 71100, France

Location status: Recruiting

Location contact

Thomas Maldiney

CONTACT

[email protected]

+33 3 85 91 01 11

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dynamic full-field optical coherence tomography analysis of kidney biopsy

Other

Dynamic full-field optical coherence tomography analysis of kidney biopsy in the nephrology department before conventional histopathological analysis

Primary outcomes

  1. 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

  1. Histopathological analysis of healthy kidney biopsy 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 healthy glomerular (glomerular basement membrane, glomerular tuft, endothelial, epithelial, and mesangial cells, glomerular capsule and capsular space, glomerular capillaries), vascular (afferent and efferent arterioles, interlobular artery) and tubulointerstitial (proximal and distal tubular cells, normal cytoplasmic aspect) structures seen in kidney biopsy

Study contacts

Contact information is provided by the study sponsor or research team.

Quentin Bernard

CONTACT

[email protected]

Thomas Maldiney

CONTACT

[email protected]

+33 3 85 91 01 11

Sponsors and collaborators

Lead sponsor

Centre Hospitalier William Morey - Chalon sur Saône

Other

Collaborators

  • Centre Hospitalier Universitaire Dijon

Registry information

Official study title

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

Acronym: NEPHROCT

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Feb 15, 2023
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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