Fibroscan Study in HCC | NCT01796145

Studies
Fibroscan Study in HCC

NCT01796145

Sponsor

Chinese University of Hong Kong

Status

Active, not recruiting

Last Update Posted

Nov 17, 2025Actual

Enrollment

207Actual

Phase

Not Applicable

Conditions

Confirmed Diagnosis of Hepatocellular Carcinoma
Patients Who Are Scheduled to Undergo Transarterial Chemobolization, Systemic Therapy Surgery
Child's A to C Cirrhosis

Interventions

Fibroscan

Countries

Hong Kong

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

Nov 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 27, 2013Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2027Estimated

First Submitted Date

Feb 20, 2013

First Submission Date that Met QC Criteria

Feb 20, 2013

First Posted Date

Feb 21, 2013Estimated

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

Nov 13, 2025

Last Update Posted Date

Nov 17, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

In patients with HCC undergoing therapy 1. We aim to determine the prognostic significance of liver stiffness in patients with HCC 2. We aim to determine the rate and severity of complications of treatment and its association with liver stiffness in patients with HCC

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

207Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
TACE	Experimental	Other: Fibroscan
Systemic Therapy	Experimental	Other: Fibroscan
Surgery	Experimental	Other: Fibroscan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fibroscan	Other		Surgery Systemic Therapy TACE

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall survival		3 years

Secondary Outcomes

Measure	Description	Time Frame
Rate and grade of treatment complications		2 years
Liver stiffness (kPa)		2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of HCC
Patients who are scheduled to undergo therapy, either TACE systemic therapy or surgery
1. For TACE cohort, patients undergoing first cycle TACE are eligible.
2. For systemic therapy cohort, patients undergoing first-line systemic therapy are eligible.
3. For surgery cohort, patient undergoing surgery are eligible.
Prior surgery or loco-ablative therapy (e.g. Radiofrequency ablation, microwave, percutaneous ethanol injection) is allowed
Child's A to Child's C liver function

Exclusion Criteria:

ECOG performance status > 2
Poorly controlled ascites

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

Not provided

Overall Officials

Name	Affiliation	Role
Stephen Lam Chan, FHKCP	Chinese University of Hong Kong	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Clinical Oncology, Prince of Wales Hospital		Hong Kong			Hong Kong