Histopathological Analysis of Renal Biopsies With Dynamic Full-field Optical Coherence Tomography, a Comparison to Conventional Histopathological Findings in Kidney Transplant Recipients (HARBOR) (HARBOR)

January 1, 2024 updated by: Centre Hospitalier William Morey - Chalon sur Saône

Histopathological Analysis of Renal Biopsies With Dynamic Full-field Optical Coherence Tomography, a Comparison to Conventional Histopathological Findings in Kidney Transplant Recipients

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Saône-et-Loire
      • Chalon sur Saône, Saône-et-Loire, France, 71100
        • Centre Hospitalier William Morey - Chalon sur Saône

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

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)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Outcome measure is assessed 15 days following kidney transplant biopsy

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Outcome measure is assessed 15 days following kidney transplant biopsy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier William Morey - Chalon sur Saône

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Centre Hospitalier Universitaire Dijon
Hôpital Necker-Enfants Malades

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dany Anglicheau, Hôpital Necker-Enfants Malades

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 14, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 2, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 1, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HARBOR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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