Clinical trial NCT01786980: The Methylation Phenotype Screening and Determination Mode Study of Liver Cancer Prognosis Related Gene
Official title: The Methylation Phenotype Screening and Determination Mode Study of Liver Cancer Prognosis Related Gene
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma;
Radical Hepatic Resection;
Lead sponsor: Eastern Hepatobiliary Surgery Hospital
Sponsor class: OTHER
First posted: 2013-02-08
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall survival
timeFrame: 2015
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Eastern Hepatobiliary Surgery Hospital
state: Shanghai
city: Shanghai
country: China
facility: Eastern hepatobilliary surgery hospital
state: Shanghai
Study officials:
References: