NCT02041780

Brief Summary

The purpose of this study is to determine if SWE and Fibrotest®/ Fibromax®, alone or associated, are effective methods to assess liver fibrosis in children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2013

Typical duration 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

Study Start

First participant enrolled

November 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 22, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

September 29, 2016

Status Verified

September 1, 2016

Enrollment Period

2.5 years

First QC Date

January 20, 2014

Last Update Submit

September 28, 2016

Conditions

Liver FibrosisChildren

Keywords

DiagnosticLiver fibrosisIshak scoreFibrotestShearWave elastographyLiver biopsies

Outcome Measures

Primary Outcomes (1)

  • liver fibrosis evaluated by the ISHAK score and morphometric evaluation

    Histology is the gold standard to evaluate liver fibrosis

    up to 1 month

Secondary Outcomes (2)

  • liver fibrosis evaluation : stiffness using SHEARWAVE elastography

    up 1 month

  • Liver fibrosis evaluation using Fibrotest (Fibromax)

    up 1 month

Study Arms (1)

Shearwave electrography

EXPERIMENTAL

Two experimental interventions will be realized in each patient in this population : Shearwave electrography (new diagnostic test of fibrosis) and Fibrotest . Moreover, liver biopsies, the gold standard for the fibrosis diagnosis is also realized in each patient within usual cares.

Procedure: Shearwave electrography

Interventions

Shearwave electrographyPROCEDURE
Shearwave electrography

Eligibility Criteria

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

You may qualify if:

  • age \< 18 years;
  • indication to liver biopsy;
  • informed consent of both parents and child if applicable;
  • social insurance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AP-HP, Bicêtre Hospital

Le Kremlin-Bicêtre, 94275, France

Location

MeSH Terms

Conditions

Liver CirrhosisDisease

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Stéphanie FRANCHI-ABELA, MD

    Assistance Publique - Hôpitaux de Paris

    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 20, 2014

First Posted

January 22, 2014

Study Start

November 1, 2013

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

September 29, 2016

Record last verified: 2016-09

Locations

FR(1)