UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014174 |
|---|---|
| Receipt number | R000010429 |
| Scientific Title | Usefulness of image enhanced endoscopy in diagnosis of the disease range of gastric cancer with undifferentiated adenocarnimoma |
| Date of disclosure of the study information | 2014/06/20 |
| Last modified on | 2018/12/10 18:01:31 |
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Basic information
Public title
Usefulness of image enhanced endoscopy in diagnosis of the disease range of gastric cancer with undifferentiated adenocarnimoma
Acronym
Diagnosis of the disease range of gastric cancer with undifferentiated adenocarnimoma
Scientific Title
Usefulness of image enhanced endoscopy in diagnosis of the disease range of gastric cancer with undifferentiated adenocarnimoma
Scientific Title:Acronym
Diagnosis of the disease range of gastric cancer with undifferentiated adenocarnimoma
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Examination of compatibility of disease range of gastric cancer with undifferentiated adenocarcinoma in endscopic diagnosis and pathological diagnoses
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Compatibility of disease range of gastric cancer with undifferentiated adenocarcinoma in endscopic diagnosis and pathological diagnoses
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Endoscopy
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Undifferentiated early gastric cancer those will be underwent endoscopic therapy or surgery
Key exclusion criteria
Patients with pacemaker inserted in
Patients diagnosed being with organic brain damage, depression or schizophrenia
Patients who doctor is inappropriate
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tai Omori |
Organization
Keio University school of medicine
Division name
Cancer Center
Zip code
Address
Shinanomachi 35, Shinjyuku-ku, Tokyo
TEL
03-3353-1211
t-omori@a3.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Rieko Nakamura |
Organization
Keio University school of medicine
Division name
Cancer Center
Zip code
Address
Shinanomachi 35, Shinjyuku-ku, Tokyo
TEL
03-3353-1211
Homepage URL
rieko-na@cam.hi-ho.ne.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
| 2014 | Year | 06 | Month | 20 | 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
| 2012 | Year | 08 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 17 | 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
| 2014 | Year | 06 | Month | 05 | Day |
Last modified on
| 2018 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010429
| 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 |
