Clinical trial NCT01930383: Circulating Tumor Cells for Hepatocellular Carcinoma
Official title: Circulating Tumor Cells (CTCs) as Biomarkers of Prognosis and Predictors of Efficacy of Drug Therapy for Patients With Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Carcinoma, Hepatocellular
Neoplasm Circulating Cells
Keywords: biomarkers
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2013-08-28
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hepatocellular carcinoma

Brief summary: To explore the clinical value of circulating tumor cells (CTCs) measurement for Hepatocellular carcinoma (HCC) patients.

Detailed description: Background:The lack of tumor tissue for drug target and biomarker studies significantly limit the development of novel treatment for advanced HCC. In recent years, circulating tumor cells (CTCs) have been shown to be important prognostic biomarkers of overall survival for patients with breast, prostate, and colorectal cancer after anti-cancer therapy.

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.

Eligibility criteria: Inclusion Criteria:

* Patient must be diagnosed with HCC via one of following methods according to present clinical practice:

  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:

* Other significant organ disease or condition his/her investigator judged that the subject should not participate in the study.

Primary outcomes:
measure: Numbers of circulating tumor cells
timeFrame: in 24 months
Secondary outcomes:
measure: Overall survival
timeFrame: 24 months
measure: Clinical characteristics
timeFrame: in 24 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Chiun Hsu, PhD
role: PRINCIPAL_INVESTIGATOR
References: