Hypermethylation of VTRNA2-1 Promoter in HCC Outcome | NCT04177316

Studies
Hypermethylation of VTRNA2-1 Promoter in HCC Outcome

NCT04177316

Sponsor

Chang Gung Memorial Hospital

Status

Completed

Last Update Posted

Nov 26, 2019Actual

Enrollment

92Actual

Phase

Not provided

Conditions

Hepatocellular Carcinoma Resectable

Interventions

Not provided

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2018Actual

Primary Completion Date

Nov 15, 2019Actual

Completion Date

Nov 15, 2019Actual

First Submitted Date

Nov 22, 2019

First Submission Date that Met QC Criteria

Nov 24, 2019

First Posted Date

Nov 26, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 24, 2019

Last Update Posted Date

Nov 26, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

92Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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%

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ming-Chin Yu, MD, PhD	Chang Gung Memorial Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ming-Chin Yu		Taoyuan		333	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012008	Recurrence

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided