UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001317
Receipt number R000001604
Scientific Title Identification of aberrant promoter methylation in liver cancer
Date of disclosure of the study information 2008/09/10
Last modified on 2010/08/17 09:17:23

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Identification of aberrant promoter methylation in liver cancer

Acronym

Identification of aberrant promoter methylation in liver cancer

Scientific Title

Identification of aberrant promoter methylation in liver cancer

Scientific Title:Acronym

Identification of aberrant promoter methylation in liver cancer

Region

Japan


Condition

Condition

Hepatocellular carcinoma

Classification by specialty

Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

To identify aberrant DNA methylation in peripheral blood and cancer tissues for early diagnosis of liver cancer

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Incidence of aberrant DNA methylation in peripheral blood and cancer tissues of liver cancer patients

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Gene

Interventions/Control_1

Aberrant DNA methylation is detected in pre- and postoperative blood samples and cancer and non-cancerous liver tissues.

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with liver cancer undergoing liver resection

Key exclusion criteria

None

Target sample size

300


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Norihiro Kokudo

Organization

Graduate School of Medicine, University of Tokyo

Division name

Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery

Zip code


Address

7-3-1, Hongo, Bunkyo-ku

TEL

03-5800-8844

Email



Public contact

Name of contact person

1st name
Middle name
Last name Takeaki Ishizawa

Organization

Graduate School of Medicine, University of Tokyo

Division name

Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery

Zip code


Address


TEL


Homepage URL


Email

tish-tky@umin.ac.jp


Sponsor or person

Institute

Graduate School of Medicine, University of Tokyo

Institute

Department

Personal name



Funding Source

Organization

Graduate School of Medicine, University of Tokyo

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Cancer Institute Hospital of Japanese Foundation for Cancer Research

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2008 Year 09 Month 10 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Date of protocol fixation

2004 Year 03 Month 17 Day

Date of IRB


Anticipated trial start date

2005 Year 05 Month 01 Day

Last follow-up date

2015 Year 03 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2008 Year 08 Month 17 Day

Last modified on

2010 Year 08 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001604


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name