NCT01613625

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2011

Completed
9 days until next milestone

Study Start

First participant enrolled

February 4, 2011

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

June 7, 2012

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 13, 2015

Completed
7.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 24, 2023

Completed
Last Updated

May 25, 2023

Status Verified

May 1, 2023

Enrollment Period

4.7 years

First QC Date

January 26, 2011

Last Update Submit

May 24, 2023

Conditions

RENAL FIBROSIS

Outcome Measures

Primary Outcomes (1)

  • the elastography

    to study a link enters the elasticity of the kidney estimated by the élastographie and the classification of the renal fibrosis estimated and quantified from the histology by draining renal biopsy.

    30 months

Secondary Outcomes (2)

  • The dosage of the créatininémie

    30 months

  • the debit of filtration glomérulaire at the child

    30 MONTHS

Study Arms (1)

Elastography

EXPERIMENTAL
Procedure: Elastography

Interventions

ElastographyPROCEDURE
Elastography

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Location

Study Officials

  • alix RUOCCO

    Assistance Publique hôpitaux de Marseille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2011

First Posted

June 7, 2012

Study Start

February 4, 2011

Primary Completion

October 13, 2015

Study Completion

May 24, 2023

Last Updated

May 25, 2023

Record last verified: 2023-05

Locations

FR(1)