Interest Of Renal Elastography In Children As A Diagnostic Tool Of Renal Fibrosis: Confrontation To Histological Features Of Renal Biopsies

NCT ID: NCT01613625

Last Updated: 2023-05-25

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

COMPLETED

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-04

Study Completion Date

2023-05-24

Brief Summary

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Elastography is a emerging imaging technique that has demonstrated high reliability in the assessment of tissues stiffness and quantification of fibrosis particularly in adult's livers. This ultrasound exploration has no secondary effects. There is no study published in the pediatric population concerning the role of ultrasound elastrography in kidney. The aim of this study is to look for a correlation between the elastography's results and the kidney fibrosis on children who have to undergo a renal biopsy. Elastography may play a potential diagnostic and/or prognostic role in the management of these patients which would limit invasive biopsy procedures.

Detailed Description

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Conditions

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RENAL FIBROSIS

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Elastography

Group Type EXPERIMENTAL

Elastography

Intervention Type PROCEDURE

Interventions

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Elastography

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Male children or feminine from 5 to 18 years old to whom is indicated a renal biopsy by the néphrologue paediatrician whatever is the initial pathology, whatever are one or several current or previous treatments and whatever is their associated comorbidity

Exclusion Criteria

* Children of less than 5 years old or more than 18 years
* Children for whom a draining renal biopsy is not or more indicated by néphrologues
* Refusal or withdrawal of the consent lit by the holders of the exercise of the parental authority or by the child if he is capable of receiving the information
* Contraindication in the realization of a draining renal biopsy (current infection, disorder of the coagulation.)
Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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alix RUOCCO

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique hôpitaux de Marseille

Locations

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Assistance Publique Hopitaux de Marseille

Marseille, , France

Site Status

Countries

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France

Other Identifiers

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2010-10

Identifier Type: OTHER

Identifier Source: secondary_id

2010-A00950-39

Identifier Type: -

Identifier Source: org_study_id

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