Circulating Tumor Cells for Hepatocellular Carcinoma
CTCs for HCC
Circulating Tumor Cells (CTCs) as Biomarkers of Prognosis and Predictors of Efficacy of Drug Therapy for Patients With Hepatocellular Carcinoma
2 other identifiers
observational
150
1 country
1
Brief Summary
To explore the clinical value of circulating tumor cells (CTCs) measurement for Hepatocellular carcinoma (HCC) patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2013
CompletedFirst Posted
Study publicly available on registry
August 28, 2013
CompletedStudy Start
First participant enrolled
October 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedNovember 14, 2013
November 1, 2013
1.8 years
August 20, 2013
November 13, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Numbers of circulating tumor cells
CTCs are measured by microfluidic disk platform. They are defined as tumor cells that are circulating in the peripheral blood of patients, which are shed from either the primary tumor or its metastases.
in 24 months
Secondary Outcomes (2)
Overall survival
24 months
Clinical characteristics
in 24 months
Study Arms (3)
Arm A
HCC patients who receive curative surgery or radiofrequency ablation therapy
Arm B
patients who receive trans-arterial chemoembolization
Arm C
patients who receive systemic therapy
Eligibility Criteria
Hepatocellular carcinoma
You may qualify if:
- Patient must be diagnosed with HCC via one of following methods according to present clinical practice:
- Diagnosed as HCC by biopsy or cytology
- Patients with chronic hepatitis B or other reason induced liver cirrhosis who have diagnosed as HCC based on a typical contrast enhanced CT or MRI profile with malignant lesion \[tumor hyper-vascularization\].
- Asian male or female subjects \>=20 years of age.
- Child-Pugh class A or B liver function..
- HCC patients who will receive anti-cancer therapy, including surgery, radiofrequency ablation therapy, trans-arterial chemoembolization, or systemic therapy (according to current HCC practice guidelines) at National Taiwan University Hospital.
- Signed informed consent.
You may not qualify if:
- Other significant organ disease or condition his/her investigator judged that the subject should not participate in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital
Taipei, 100, Taiwan
Biospecimen
The blood samples will be separated to blood cells and plasma. Blood cells will be used for isolation and enumeration of CTCs. Plasma will be used to extract DNA to measure molecular aberration (gene mutations related to hepatocarcinogenesis or response of HCC cells to molecular targeted therapy).
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chiun Hsu, PhD
National Taiwan University Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2013
First Posted
August 28, 2013
Study Start
October 1, 2013
Primary Completion
August 1, 2015
Last Updated
November 14, 2013
Record last verified: 2013-11