NCT02060565

Brief Summary

The aim of this retrospective and prospective study is to evaluate the 20-year prognosis value of non-invasive methods for the diagnosis of chronic liver disease for predicting survival and complications of cirrhosis.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
94mo left

Started Feb 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress62%
Feb 2014Feb 2034

Study Start

First participant enrolled

February 1, 2014

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

February 11, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 12, 2014

Completed
15.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2030

Expected
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2034

Last Updated

July 20, 2023

Status Verified

July 1, 2023

Enrollment Period

15.9 years

First QC Date

February 11, 2014

Last Update Submit

July 19, 2023

Conditions

Chronic Liver Disease

Keywords

diagnosissurvivalnon-invasive methodcirrhosisFibroScan

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    20 years

Secondary Outcomes (1)

  • Survival without liver complications

    20 years

Other Outcomes (1)

  • Survival without liver transplantation

    20 years

Study Arms (1)

Chronic liver disease

all patients with chronic liver disease followed using non-invasive methods

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all consecutive patients with an age over eighteen and chronic liver disease

You may qualify if:

  • chronic hepatitis C
  • chronic hepatitis B
  • alcohol liver disease
  • non alcoholic liver disease

You may not qualify if:

  • ascitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre d'Investigation de la Fibrose hépatique Service Hépato-Gastroentérologie Hopital Haut-Lévèque

Pessac, 33200, France

RECRUITING

MeSH Terms

Conditions

DiseaseFibrosis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Juliette Foucher, MD

    Association HGE CHU Bordeaux Sud

    STUDY CHAIR

  • Faiza Chermak, MD

    Association HGE CHU Bordeaux Sud

    STUDY CHAIR

  • Victor de Lédinghen, MD, PhD

    Association HGE CHU Bordeaux Sud

    STUDY DIRECTOR

  • Jean-Baptiste Hiriart, MD

    Association HGE CHU Bordeaux Sud

    STUDY CHAIR

Central Study Contacts

Victor de Lédinghen, MD, PhD

CONTACT

0033557656439victor.deledinghen@chu-bordeaux.fr

Juliette Foucher

CONTACT

0033557656439juliette.foucher@chu-bordeaux.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2014

First Posted

February 12, 2014

Study Start

February 1, 2014

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

February 1, 2034

Last Updated

July 20, 2023

Record last verified: 2023-07

Locations

FR(1)