UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003899
Receipt number R000004690
Scientific Title Analysis of HE4(WFDC2) expression as a new candidate molecular marker of gastric cancer.
Date of disclosure of the study information 2010/07/09
Last modified on 2012/09/17 09:49:05

* 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

Analysis of HE4(WFDC2) expression as a new candidate molecular marker of gastric cancer.

Acronym

Analysis of gene expressions of new candidates for gastric cancer molecular markers.

Scientific Title

Analysis of HE4(WFDC2) expression as a new candidate molecular marker of gastric cancer.

Scientific Title:Acronym

Analysis of gene expressions of new candidates for gastric cancer molecular markers.

Region

Japan


Condition

Condition

Gastric Cancer

Classification by specialty

Gastroenterology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Gastric cancer remains the second leading cause of cancer-related death worldwide.
We recently reported that HE4(WFDC2) was expressed in both gastric metaplasia and intestinal metaplasia, furthermore, HE4 expressed in the vast majority of intestinal type and signet ring gastric adenocarcinomas.
*Nozaki K et al. Gastroenterology 134(2):511-522, 2008.
In this study, we evaluate up-regulation of this novel secreted mediator, HE4(WFDC2), as surrogate marker of the preneoplastic process.

Basic objectives2

Bio-availability

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

HE4(WFDC2) mRNA expression level and protein transcripts, OS(Overall Survival), progression and pathological / biological characteristics of the gastric cancers.

Key secondary outcomes

HE4(WFDC2) mRNA expression level and protein transcripts, before surgical resection of gastric cancer, after surgical resection, during adjuvant chemotherapy, and after chemotherapy.


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

Gastric cancer patients, who have been notified about the diagnosis, and have planned for admission for surgical resection of gastric cancer.

Key exclusion criteria

Not applied

Target sample size

300


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Koji Nozaki MD, PhD

Organization

The University of Tokyo Hospital

Division name

Gastrointestinal Surgery

Zip code


Address

7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, JAPAN

TEL

03-3815-5411

Email



Public contact

Name of contact person

1st name
Middle name
Last name Koji Nozaki MD, PhD

Organization

The University of Tokyo Hospital

Division name

Clinical Research Support Center

Zip code


Address

7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, JAPAN

TEL

03-3815-5411

Homepage URL


Email

knozaki-tky@umin.ac.jp


Sponsor or person

Institute

The University of Tokyo

Institute

Department

Personal name



Funding Source

Organization

Grants-in-Aid for Scientific Research

Organization

Division

Category of Funding Organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


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

2010 Year 07 Month 09 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

Completed

Date of protocol fixation

2009 Year 07 Month 27 Day

Date of IRB


Anticipated trial start date

2010 Year 07 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information


Management information

Registered date

2010 Year 07 Month 09 Day

Last modified on

2012 Year 09 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004690


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name