Prognosis Value of Non-invasive Methods for the Diagnosis... | NCT02060565

Studies
Prognosis Value of Non-invasive Methods for the Diagnosis of Chronic Liver Disease

NCT02060565

Sponsor

Association HGE CHU Bordeaux Sud

Status

Recruiting

Last Update Posted

Jul 20, 2023Actual

Enrollment

10,000Estimated

Phase

Not provided

Conditions

Chronic Liver Disease

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2014Actual

Primary Completion Date

Jan 2030Estimated

Completion Date

Feb 2034Estimated

First Submitted Date

Feb 11, 2014

First Submission Date that Met QC Criteria

Feb 11, 2014

First Posted Date

Feb 12, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 19, 2023

Last Update Posted Date

Jul 20, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

All consecutive patients with chronic liver disease will be followed during 20 years.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Chronic liver disease		all patients with chronic liver disease followed using non-invasive methods

Interventions

Not provided

Measure	Description	Time Frame
Overall survival		20 years

Measure	Description	Time Frame
Survival without liver complications		20 years

Measure	Description	Time Frame
Survival without liver transplantation		20 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

ascitis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Victor de Lédinghen, MD, PhD	Contact	0033557656439		victor.deledinghen@chu-bordeaux.fr
Juliette Foucher	Contact	0033557656439		juliette.foucher@chu-bordeaux.fr

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre d'Investigation de la Fibrose hépatique Service Hépato-Gastroentérologie Hopital Haut-Lévèque	Recruiting	Pessac		33200	France

Condition Browse Module

MeSH Terms

ID	Term
D004194	Disease
D005355	Fibrosis

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided