UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013437 |
|---|---|
| Receipt number | R000015687 |
| Scientific Title | International multi-centric study on the interpretation of confocal laser endomicroscopy(CLE) in collaboration of German and Japanese institutions. |
| Date of disclosure of the study information | 2014/03/17 |
| Last modified on | 2015/09/01 11:08:18 |
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Basic information
Public title
International multi-centric study on the interpretation of confocal laser endomicroscopy(CLE) in collaboration of German and Japanese institutions.
Acronym
International multi-centric study on the interpretation of confocal laser endomicroscopy(CLE) in collaboration of German and Japanese institutions.
Scientific Title
International multi-centric study on the interpretation of confocal laser endomicroscopy(CLE) in collaboration of German and Japanese institutions.
Scientific Title:Acronym
International multi-centric study on the interpretation of confocal laser endomicroscopy(CLE) in collaboration of German and Japanese institutions.
Region
| Japan | Europe |
Condition
Condition
Non-polypoid or depressed type lesions
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To elucidate supplemental diagnostic value of CLE over white light endoscopy(WLE), and also the reliability and reproducibility of the deferential diagnosis for superficial GI lesions using CLE by comparing outcomes by nations, GI endoscopy experience and CLE experience of reviewers and also diseases.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The accuracies of the differential diagnosis of WLE and WLE+CLE.
Key secondary outcomes
The diversity of the differential diagnosis of WLE and WLE+CLE among groups of the reviewers and also among the diagnosis.
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
| 18 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients underwent confocal laser endoscopic examinations for gastric lesions at the Jikei University Hospital.
Key exclusion criteria
None.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuki Sumiyama |
Organization
The Jikei University School of Medicne
Division name
Department of Endoscopy
Zip code
Address
3-25-8, Nishi-shimbashi, Minato-ku, Tokyo, Japan, Nishi-shimbashi, Minato-ku, Tokyo, Japan
TEL
03-3433-1111
kaz_sum@jikei.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuki Sumiyama |
Organization
The Jikei University School of Medicine
Division name
Department of Endoscopy
Zip code
Address
3-25-8, Nishi-shimbashi, Minato-ku, Tokyo, Japan
TEL
03-3433-1111
Homepage URL
kaz_sum@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine
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
Osaka University
The University of Tokyo
National Cancer Center
St. Marienkrankenhaus Frankfurt Germany
Universitatsklinikum Erlangen Germany
Klinikum Bayreuth Germany
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
大阪大学病院（大阪府）
東京大学病院（東京都）
国立癌センター（東京都）
フランクフルト大学病院(独)
エルランゲン大学病院(独)
バイロイト病院(独)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 03 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2013 | Year | 11 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | 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
Randomized samples
A retrospective study
Management information
Registered date
| 2014 | Year | 03 | Month | 17 | Day |
Last modified on
| 2015 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015687
| 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 |
