Assessing Signatures for Fibrosis Detection in Chronic Li... | NCT07359742

Studies
Assessing Signatures for Fibrosis Detection in Chronic Liver Disease: A Step Beyond Conventional Biomarkers

NCT07359742

Sponsor

Universitair Ziekenhuis Brussel

Status

Recruiting

Last Update Posted

May 6, 2026Actual

Enrollment

110Estimated

Phase

Not Applicable

Conditions

Chronic Liver Disease (CLD)
Fibrosis of Liver

Interventions

Blood draw for biomarkers

Countries

Belgium

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

Apr 2026

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

May 2026Estimated

Primary Completion Date

Jan 2028Estimated

Completion Date

Jan 2028Estimated

First Submitted Date

Dec 8, 2025

First Submission Date that Met QC Criteria

Jan 15, 2026

First Posted Date

Jan 22, 2026Actual

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

Apr 30, 2026

Last Update Posted Date

May 6, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Morbidity and mortality of CLD is driven by the extent of liver fibrosis, characterized by scar formation and disruption of the normal liver architecture. HSCs play a central role in liver fibrosis development. When hepatocytes are damaged, HSCs undergo myofibroblast differentiation, transitioning into an activated state. So far, no efficient biomarkers can estimate the degree of HSC activation or reversal across all aetiologies of CLD, although this could be a more sensitive marker than fibrosis measurement which is secondary to HSC activation. This study aims to correlate biomarkers to the fibrosis stage in a larger cohort of patients with CLD across all aetiologies.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

110Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
EDTA tube	Experimental		Other: Blood draw for biomarkers

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood draw for biomarkers	Other	EDTA tube Blood draw for biomarkers	EDTA tube

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
correlation of biomarkers in blood and fibrosis stage of liver	correlation of biomarkers in blood and fibrosis stage of the liver (comparison with: transient elastography, fib4, APRI and liver biopsy if possible)	Day 1 of the study

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

≥18y
Chronic liver disease: alcohol, metabolic dysfunction associated steatotic liver disease, viral hepatitis, autoimmune hepatitis, cholestatic liver disease and hemochromatosis

Exclusion Criteria:

<18y
Acute hepatitis
Contra-indication for transient elastography (Fibroscan®) such as ascites or overt heart failure.

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Silke François	Contact	+32 2 477 60 11		silke.francois@uzbrussel.be

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UZ Brussel	Recruiting	Brussels		1090	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008103	Liver Cirrhosis
D005355	Fibrosis

Ancestor Terms

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection
D015415	Biomarkers

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided