UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003899
Receipt No. 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

* 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
Institute The University of Tokyo
Institute
Department

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
URL(English) https://upload.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


Contact us.