UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000001799
Receipt No. R000002169
Scientific Title Analysis of usefulness of serum TFF1, 2, 3 mesurement for gastric cancer screening
Date of disclosure of the study information 2009/04/01
Last modified on 2014/03/25

* 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 usefulness of serum TFF1, 2, 3 mesurement for gastric cancer screening
Acronym Gastric cancer screening using serum TFF1, 2, 3
Scientific Title Analysis of usefulness of serum TFF1, 2, 3 mesurement for gastric cancer screening
Scientific Title:Acronym Gastric cancer screening using serum TFF1, 2, 3
Region
Japan

Condition
Condition gastric cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To know whether serum TFF1, 2, and 3 can be good screening markers for gastric cancer in health check receiving people.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Whether serum TFF1, 2, and 3 value can select people who should receive endoscopic examination for gastric cancer.
Key secondary outcomes Whether serum TFF1, 2 and 3 are better screening marker for gastric cancer than pepsinogen method.

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 Who agreed to participate in the study among people who receive health check program in NTT east Japan Kanto Hospital
Key exclusion criteria Nothing
Target sample size 20000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sachiyo Nomura
Organization Graduate School of Medicine, the University of Tokyo
Division name Department of Gastrointestinal Surgery
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL 03-3815-5411
Email snomura-gi@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nobuyuki Matsuhashi
Organization NTT east Japan Kanto Hospital
Division name Endoscopy division
Zip code
Address 5-9-22 Higashi Gotanda, Shinagawa-ku
TEL 03-3448-6245
Homepage URL
Email nmatuha-tky@umin.ac.jp

Sponsor
Institute Serum TFF analyzing group
Institute
Department

Funding Source
Organization The University of Tokyo
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor NTT East Japan Kanto Hospital
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
2009 Year 04 Month 01 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 Terminated
Date of protocol fixation
2009 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 01 Day
Last follow-up date
2012 Year 03 Month 01 Day
Date of closure to data entry
2012 Year 03 Month 01 Day
Date trial data considered complete
2012 Year 09 Month 01 Day
Date analysis concluded
2013 Year 03 Month 01 Day

Other
Other related information The participants receive upper gastrointestinal endoscopy and are diagnosed whether they have gastric caner or not.

Management information
Registered date
2009 Year 03 Month 25 Day
Last modified on
2014 Year 03 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002169

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.