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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000025605
Receipt No. R000029413
Scientific Title application of tissue-clearing technique to pathological assessment of gastrointestinal tumorous lesions
Date of disclosure of the study information 2017/01/10
Last modified on 2017/01/10

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Basic information
Public title application of tissue-clearing technique to pathological assessment of gastrointestinal tumorous lesions
Acronym three-dimensional visualization and reconstruction with tissue-clearing technique
Scientific Title application of tissue-clearing technique to pathological assessment of gastrointestinal tumorous lesions
Scientific Title:Acronym three-dimensional visualization and reconstruction with tissue-clearing technique
Region
Japan

Condition
Condition gastrointestinal tumorous lesion and background mucosa
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 efficacy of three-dimensional image reconstruction of gastrointestinal specimens obtained by endoscopic resection or biopsy by use of novel tissue-clearing technique: LUCID
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes efficacy of tissue-clearing technique including observable depth by fluorescent microscopy
Key secondary outcomes

Base
Study type Others,meta-analysis etc

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 gastrointestinal tumorous lesion or mucosa obtained by endoscopic resection or biopsy
Key exclusion criteria none
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Ono
Organization University of Tokyo Hospital
Division name Department of gastroenterology
Zip code
Address 7-3-1, Hongo, Bunkyo, Tokyo
TEL 03-3815-5411
Email satoshi-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Ono
Organization University of Tokyo Hospital
Division name Department of gastroenterology
Zip code
Address 7-3-1, Hongo, Bunkyo, Tokyo
TEL 03-3815-5411
Homepage URL
Email satoshi-tky@umin.ac.jp

Sponsor
Institute University of Tokyo
Institute
Department

Funding Source
Organization AMED
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 01 Month 10 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
Date of protocol fixation
2016 Year 07 Month 05 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none particular

Management information
Registered date
2017 Year 01 Month 10 Day
Last modified on
2017 Year 01 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029413

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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