Back to resultsFibroscan Study in HCC
Primary Purpose
Confirmed Diagnosis of Hepatocellular Carcinoma, Patients Who Are Scheduled to Undergo Transarterial Chemobolization, Systemic Therapy Surgery, Child's A to C Cirrhosis
Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Fibroscan
Sponsored by
About this trial
This is an interventional other trial for Confirmed Diagnosis of Hepatocellular Carcinoma
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of HCC
Patients who are scheduled to undergo therapy, either TACE systemic therapy or surgery
- For TACE cohort, patients undergoing first cycle TACE are eligible.
- For systemic therapy cohort, patients undergoing first-line systemic therapy are eligible.
- 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
Sites / Locations
- Department of Clinical Oncology, Prince of Wales HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
TACE
Systemic Therapy
Surgery
Arm Description
Outcomes
Primary Outcome Measures
Overall survival
Secondary Outcome Measures
Rate and grade of treatment complications
Liver stiffness (kPa)
Full Information
NCT ID
NCT01796145
First Posted
February 20, 2013
Last Updated
March 6, 2023
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT01796145
Brief Title
Fibroscan Study in HCC
Official Title
A Study to Evaluate the Impact of Liver Stiffness on Treatment Outcome of Hepatocellular Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 27, 2013 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Confirmed Diagnosis of Hepatocellular Carcinoma, Patients Who Are Scheduled to Undergo Transarterial Chemobolization, Systemic Therapy Surgery, Child's A to C Cirrhosis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TACE
Arm Type
Experimental
Arm Title
Systemic Therapy
Arm Type
Experimental
Arm Title
Surgery
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Fibroscan
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Rate and grade of treatment complications
Time Frame
2 years
Title
Liver stiffness (kPa)
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of HCC
Patients who are scheduled to undergo therapy, either TACE systemic therapy or surgery
For TACE cohort, patients undergoing first cycle TACE are eligible.
For systemic therapy cohort, patients undergoing first-line systemic therapy are eligible.
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephen Lam Chan, FHKCP
Phone
35051042
Email
l_chan@clo.cuhk.edu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Nicole Yim, RN
Phone
3505 1046
Email
nicole@clo.cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Lam Chan, FHKCP
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Clinical Oncology, Prince of Wales Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen Lam Chan, FHKCP
Phone
3505 1042
Email
l_chan@clo.cuhk.edu.hk
First Name & Middle Initial & Last Name & Degree
Nicole Yim, RN
Phone
3505 1046
Email
nicole@clo.cuhk.edu.hk
First Name & Middle Initial & Last Name & Degree
Stephen Lam Chan, FHKCP
12. IPD Sharing Statement
Learn more about this trial
Fibroscan Study in HCC
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