Clinical Trial on Hepatocellular Carcinoma;, Radical Hepatic Resection; - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Detailed Description

Recurrence and metastasis are the main factors affecting the prognosis of liver cancer after curative resection. Establishing an effective prognostic evaluation method is able to not only assess patients' prognosis but also guide the treatment. At the same time, it helps us to gain knowledge of the mechanism underlying recurrence and metastasis of liver cancer and to provide the basis for the search for new effective intervention method.

In order to establish an effective prognostic evaluation method, we select liver cancer patients undergoing curative resection in our hospital. We plan to employ various technologies such as gene chip, methylation chip and flow cytometry to carry out comprehensive researches on liver cancer cell genetics, epigenetics, stem cells and tumor microenvironment changes. By analyzing clinical information including pathological features, patients' response to treatment, relapse, metastasis and survival, we aim to obtain the important factors affecting liver cancer prognosis, survival, recurrence and metastasis in order to be able to find and establish the effective prognostic evaluation method.

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

China
- Shanghai
  - Shanghai, Shanghai, China, 200438
    - Eastern hepatobilliary surgery hospital
  - Shanghai, Shanghai, China, 200438
    - Eastern Hepatobiliary Surgery Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The patients with radical hepatectomy in Eastern Hepatobiliary Surgery Hospital, and were confirmed hepatocellular carcinoma pathologically. The liver function was Child-Pugh A, as well as the Child-Pugh B achieved to A after treatment, and the HAI score of cirrhosis was <12.

Description

Inclusion Criteria:

Patients with radical hepatectomy in Eastern Hepatobiliary Surgery Hospital;
Hepatocellular carcinoma confirmed pathologically;
The liver function is Child-Pugh A, as well as the Child-Pugh B achieved to A after treatment;
The HAI score of cirrhosis <12

Exclusion Criteria:

Patients with apparent cardiac, pulmonary, cerebric and renal dysfunction,which may affect the treatment of liver cancer.
Patients with other diseases which may affect the treatment mentioned here.
Patients with medical history of other malignant tumors.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
liver cancer, Radical hepatic resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall survival Time Frame: 2015	2015

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eastern Hepatobiliary Surgery Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

February 6, 2013

First Submitted That Met QC Criteria