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)

NCT ID: NCT05728216

Last Updated: 2024-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-01

Study Completion Date

2025-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Kidney Injury Chronic Kidney Diseases Tomography, Optical Coherence

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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NEPHROCT cohort

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

Dynamic full-field optical coherence tomography analysis of kidney biopsy

Intervention Type OTHER

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

Interventions

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Dynamic full-field optical coherence tomography analysis of kidney biopsy

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role collaborator

Centre Hospitalier William Morey - Chalon sur Saône

OTHER

Sponsor Role lead

Responsible Party

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Thomas Maldiney

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thomas Maldiney

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier William Morey - Chalon sur Saône

Locations

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Centre Hospitalier William Morey - Chalon sur Saône

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

Site Status RECRUITING

Countries

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France

Central Contacts

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Thomas Maldiney

Role: CONTACT

+33 3 85 91 01 11

Quentin Bernard

Role: CONTACT

Facility Contacts

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Thomas Maldiney

Role: primary

+33 3 85 91 01 11

References

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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.

Reference Type BACKGROUND
PMID: 34921054 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26605118 (View on PubMed)

Other Identifiers

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NEPHROCT

Identifier Type: -

Identifier Source: org_study_id

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