Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
150 participants
OBSERVATIONAL
2013-10-31
Brief Summary
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Detailed Description
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Methods and Materials:This project plans to enroll 50 HCC patients who receive curative surgery or radiofrequency ablation therapy, 50 patients who receive trans-arterial chemoembolization, and 50 patients who receive systemic therapy at National Taiwan University Hospital in 24 months for CTCs analysis. The eligible patients will receive blood tests before and after anti-cancer therapy. 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)
1. to explore the correlation between CTCs numbers and other clinical characteristics in HCC patients with different stages;
2. to compare the patterns of molecular aberrations between CTC and HCC tumor tissue in HCC patients who have archival tumor tissue available; and
3. to measure the changes of CTCs numbers and molecular aberrations in HCC patients before and after molecular targeted therapy.
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Arm A
HCC patients who receive curative surgery or radiofrequency ablation therapy
No interventions assigned to this group
Arm B
patients who receive trans-arterial chemoembolization
No interventions assigned to this group
Arm C
patients who receive systemic therapy
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
1. Diagnosed as HCC by biopsy or cytology
2. 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.
Exclusion Criteria
20 Years
ALL
No
Sponsors
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National Taiwan University Hospital
OTHER
Responsible Party
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Principal Investigators
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Chiun Hsu, PhD
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University Hospital
Locations
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National Taiwan University Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Other Identifiers
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ctcs201305
Identifier Type: OTHER
Identifier Source: secondary_id
201306057RIND
Identifier Type: -
Identifier Source: org_study_id