UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014377 |
|---|---|
| Receipt number | R000016739 |
| Scientific Title | A prospective study of usefulness of acetic acid-indigocarmine mixture for diagnosis of horizontal margin of gastric mucosal tumors just before ESD |
| Date of disclosure of the study information | 2014/06/25 |
| Last modified on | 2015/07/13 12:02:10 |
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Basic information
Public title
A prospective study of usefulness of acetic acid-indigocarmine mixture for diagnosis of horizontal margin of gastric mucosal tumors just before ESD
Acronym
A prospective study of AIM for diagnosis of horizontal margin of gastric tumors just before ESD.
Scientific Title
A prospective study of usefulness of acetic acid-indigocarmine mixture for diagnosis of horizontal margin of gastric mucosal tumors just before ESD
Scientific Title:Acronym
A prospective study of AIM for diagnosis of horizontal margin of gastric tumors just before ESD.
Region
| Japan |
Condition
Condition
gastric mucosal tumors
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To prove the usefulness of AIM for diagnosis of horizontal margin of gastric mucosal tumors just before ESD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The correspondence of horizontal margin of gastric mucosal tumores diagnosed by AIM spraying with by pathological examination.
Key secondary outcomes
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
The patients whose gastric mucosal neoplasms will be treated by ESD in our hospital and who agree to the study.
Key exclusion criteria
The patients who do not agree to the study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Motoyoshi Izumi |
Organization
Machida municipal hospital
Division name
department of Gastroenterology
Zip code
Address
2-15-41, Asahi-machi, Machida-city, Tokyo
TEL
042-722-2230
m.izumi@machida-city-hp.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Emiko Tanida |
Organization
Machida municipal hospital
Division name
department of Gastroenterology
Zip code
Address
2-15-41, Asahi-machi, Machida-city, Tokyo
TEL
042-722-2230
Homepage URL
e.tanida@machida-city-hp.jp
Sponsor or person
Institute
Machida municipal hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
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 | 25 | 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
| 2014 | Year | 06 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2015 | Year | 05 | Month | 30 | Day |
Date of closure to data entry
| 2015 | Year | 05 | Month | 30 | Day |
Date trial data considered complete
| 2015 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2015 | Year | 09 | Month | 30 | Day |
Other
Other related information
During analysis
Management information
Registered date
| 2014 | Year | 06 | Month | 25 | Day |
Last modified on
| 2015 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016739
