UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001799 |
|---|---|
| Receipt number | 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 09:56:19 |
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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
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
nmatuha-tky@umin.ac.jp
Sponsor or person
Institute
Serum TFF analyzing group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002169
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
