Circulating Tumor Cells for Hepatocellular Carcinoma

• Conditions: Carcinoma, Hepatocellular; Neoplasm Circulating Cells

• Registration Number: NCT01930383
• Lead Sponsor: National Taiwan University Hospital

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.

Study Timeline

• Study First Submitted: 2013-08-20
• Study First Submitted QC: 2013-08-23
• Study First Posted: 2013-08-28
• Study Start: 2013-10
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-13
• Last Update Posted: 2013-11-14
• Primary Completion: 2015-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Numbers of circulating tumor cells	in 24 months	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.

Secondary Outcome Measures

Name	Time	Method
Overall survival	24 months
Clinical characteristics	in 24 months	The other clinical characteristics was defined as following characteristics: 1. Sex; 2. Age; 3. Barcelona-Clinic Liver Cancer\[BCLC\] staging; 4. alpha feto protein\[AFP\] level; 5. Time to progression

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan