Clinical trial 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)
Official 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Kidney Injury
Chronic Kidney Diseases
Tomography, Optical Coherence
Keywords: Tomography, Optical Coherence
Chronic Kidney Diseases
Acute Kidney Injury
Kidney Biopsy
Lead sponsor: Centre Hospitalier William Morey - Chalon sur Saône
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire Dijon
First posted: 2023-02-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients \> 18 years of age with suspected acute kidney injury or chronic kidney disease requiring biopsy in the nephrology department

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.


Eligibility criteria: 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

Primary outcomes:
measure: Histopathological analysis of elementary lesions in nephropathology with dynamic full-field optical coherence tomography
timeFrame: Outcome measure is assessed 15 days following kidney biopsy
Secondary outcomes:
measure: Histopathological analysis of healthy kidney biopsy with dynamic full-field optical coherence tomography
timeFrame: Outcome measure is assessed 15 days following kidney 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: Centre Hospitalier William Morey - Chalon sur Saône
name: Thomas Maldiney
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hull KL, Adenwalla SF, Topham P, Graham-Brown MP. Indications and considerations for kidney biopsy: an overview of clinical considerations for the non-specialist. Clin Med (Lond). 2022 Jan;22(1):34-40. doi: 10.7861/clinmed.2021-0472. Epub 2021 Dec 17.
citation: Jain M, Robinson BD, Salamoon B, Thouvenin O, Boccara C, Mukherjee S. Rapid evaluation of fresh ex vivo kidney tissue with full-field optical coherence tomography. J Pathol Inform. 2015 Sep 28;6:53. doi: 10.4103/2153-3539.166014. eCollection 2015.