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Hypermethylation of VTRNA2-1 Promoter in HCC Outcome

Sponsor
Chang Gung Memorial Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04177316
Collaborator
(none)
92
Enrollment
1
Location
11.5
Actual Duration (Months)
8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    92 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Differential Hypermethylation Status of the VTRNA2-1 Promoter in Hepatocellular Carcinoma as an Independent Factor After Partial Hepatectomy
    Actual Study Start Date :
    Dec 1, 2018
    Actual Primary Completion Date :
    Nov 15, 2019
    Actual Study Completion Date :
    Nov 15, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    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%

    Outcome Measures

    Primary Outcome Measures

    1. disease free survival (DFS) [a month]

      The length of time from curative hepatectomies treatment and recurrence or mortality

    Secondary Outcome Measures

    1. Overall survival [a month]

      The length of time from hepatectomies treatment for HCC and still alive.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 85 Years
    Sexes Eligible for Study:
    All
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ming-Chin Yu Taoyuan Taiwan 333

    Sponsors and Collaborators

    • Chang Gung Memorial Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chang Gung Memorial Hospital
    ClinicalTrials.gov Identifier:
    NCT04177316
    Other Study ID Numbers:
    • 201801969B0
    First Posted:
    Nov 26, 2019
    Last Update Posted:
    Nov 26, 2019
    Last Verified:
    Nov 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Chang Gung Memorial Hospital
    VTRNA2-1 promoter
    recurrence
    methylation
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Hepatocellular

    Study Results

    No Results Posted as of Nov 26, 2019