Hypermethylation of VTRNA2-1 Promoter in HCC Outcome

Differential Hypermethylation Status of the VTRNA2-1 Promoter in Hepatocellular Carcinoma as an Independent Factor After Partial Hepatectomy

The clinic-pathological data were retrieved from the cancer registry database from the Cancer Center of Chang Gung Memorial Hospital, Linkou branch. Of the 92 HCC patients with partial hepatectomies enrolled. The biological specimen was studied with approval.

Study Overview

• Status: Completed
• Conditions: Hepatocellular Carcinoma Resectable

Detailed Description

This study was approved by the Institute Review Board (IRB) of Chang Gung Memorial Hospital, Linkou Branch (IRB 201801969B0). The clinic-pathological data were retrieved from the cancer registry database from the Cancer Center of Chang Gung Memorial Hospital, Linkou branch. Of the 92 HCC patients with partial hepatectomies enrolled, all patients had curative hepatectomy and those with different cancers were excluded. HCC tumor tissue and normal tissue, 3 cm from the tumor margin, were stored immediately in a -80 degree freezer at the Central Biobank of Chang Gung Memorial Hospital. The personal information was protected with decoding and registered with number.

• Study Type: Observational
• Enrollment (Actual): 92

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan, Taiwan, 333
    • Ming-Chin Yu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

HCC patients with curative partial hepatectomies and the pathology reports proved.

Description

Inclusion Criteria:

subjects with pathologic diagnosis of hepatocellular carcinoma curative partial hepatectomies

Exclusion Criteria:

history of different malignant disease. subjects cannot be treated with curative surgery.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
hypermethylation; The hypermethylation group was defined as differential methylation status of tumor- normal ≥ 5%.
hypomethylation/no change; The hypomethylation were defined as differential methylation status of tumor- normal <5%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
disease free survival (DFS)	The length of time from curative hepatectomies treatment and recurrence or mortality	a month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	The length of time from hepatectomies treatment for HCC and still alive.	a month

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Study Chair: Ming-Chin Yu, MD, PhD, Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): November 15, 2019
• Study Completion (Actual): November 15, 2019

Study Registration Dates

• First Submitted: November 22, 2019
• First Submitted That Met QC Criteria: November 24, 2019
• First Posted (Actual): November 26, 2019

Study Record Updates

• Last Update Posted (Actual): November 26, 2019
• Last Update Submitted That Met QC Criteria: November 24, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: recurrence; methylation; VTRNA2-1 promoter
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: 201801969B0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No