Circulating Tumor Cells for Hepatocellular Carcinoma

Carcinoma, Hepatocellular Clinical Trial

— CTCs for HCC  

Official title:

Circulating Tumor Cells (CTCs) as Biomarkers of Prognosis and Predictors of Efficacy of Drug Therapy for Patients With Hepatocellular Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01930383
• Other study ID #: 201306057RIND
• Secondary ID: ctcs201305
• Status: Recruiting
• Phase: N/A
• First received: August 20, 2013
• Last updated: November 13, 2013
• Start date: October 2013

Study information

• Verified date: November 2013
• Source: National Taiwan University Hospital
• Contact: Chiun Hsu, PhD
• Phone: 886-2-23123456
• Email: chsu1967[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Neoplasm Circulating Cells
• Neoplastic Cells, Circulating

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Overall survival		24 months	No
Secondary	Clinical characteristics	The other clinical characteristics was defined as following characteristics: Sex; Age; Barcelona-Clinic Liver Cancer[BCLC] staging; alpha feto protein[AFP] level; Time to progression	in 24 months	No