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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01786980
Other study ID # 2012ZX1000201600104
Secondary ID
Status Completed
Phase N/A
First received February 6, 2013
Last updated March 30, 2016
Start date October 2012
Est. completion date December 2015

Study information

Verified date March 2016
Source Eastern Hepatobiliary Surgery Hospital
Contact n/a
Is FDA regulated No
Health authority China: Ministry of Health
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

1. Patients with radical hepatectomy in Eastern Hepatobiliary Surgery Hospital;

2. Hepatocellular carcinoma confirmed pathologically;

3. The liver function is Child-Pugh A, as well as the Child-Pugh B achieved to A after treatment;

4. The HAI score of cirrhosis <12

Exclusion Criteria:

1. Patients with apparent cardiac, pulmonary, cerebric and renal dysfunction,which may affect the treatment of liver cancer.

2. Patients with other diseases which may affect the treatment mentioned here.

3. Patients with medical history of other malignant tumors.

Study Design

Time Perspective: Prospective


Locations

Country Name City State
China Eastern Hepatobiliary Surgery Hospital Shanghai Shanghai
China Eastern hepatobilliary surgery hospital Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Eastern Hepatobiliary Surgery Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall survival 2015 Yes