UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026662 |
|---|---|
| Receipt number | R000030616 |
| Scientific Title | Observation of the digestive tract using confocal laser endomicroscopy (Cellvizio) |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2018/03/24 09:58:49 |
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Basic information
Public title
Observation of the digestive tract using confocal laser endomicroscopy (Cellvizio)
Acronym
Observation of the digestive tract using confocal laser endomicroscopy (Cellvizio)
Scientific Title
Observation of the digestive tract using confocal laser endomicroscopy (Cellvizio)
Scientific Title:Acronym
Observation of the digestive tract using confocal laser endomicroscopy (Cellvizio)
Region
| Japan |
Condition
Condition
gastrointestinal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To confirm acrinol can stain nucleus under observation using confocal laser endomicroscopy (Cellvizio)
Basic objectives2
Others
Basic objectives -Others
To confirm acrinol can stain nucleus under observation using confocal laser endomicroscopy (Cellvizio)
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Acrinol can stain nucleus of the gastrointestinal cancer under observation using confocal laser endomicroscopy (Cellvizio)
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
patients who receive resection of gastrointestinal cancer in our institution
Key exclusion criteria
patients without permission
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Youichi Kumagai |
Organization
Saitama Medical center, Saitama Medical University
Division name
Department of Digestive tract and General Surgery
Zip code
Address
1981 Kamoda, Kawagoe-shi, saitama-ken
TEL
049-228-3619
kuma7srg1@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Youichi Kumagai |
Organization
Saitama Medical center, Saitama Medical University
Division name
Department of Digestive tract and General Surgery
Zip code
Address
1981 Kamoda, Kawagoe-shi, saitama-ken
TEL
049-228-3619
Homepage URL
kuma7srg1@gmail.com
Sponsor or person
Institute
Saitama Medical 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
Mauna Kea technology
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
| 2017 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Acrinol can stain nucleus under observation using confocal laser endomicroscopy.
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
| 2017 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2017 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2017 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2017 | Year | 06 | Month | 01 | Day |
Other
Other related information
We use surgically resected specimens
Management information
Registered date
| 2017 | Year | 03 | Month | 23 | Day |
Last modified on
| 2018 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030616
| 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 |
