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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035951
Receipt No. R000040947
Scientific Title Validation of a novel histopathological auto-diagnosis system of gastrointestinal tumor using the tissue cleaning technology (LUCID)
Date of disclosure of the study information 2019/03/01
Last modified on 2019/02/20

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Basic information
Public title Validation of a novel histopathological auto-diagnosis system of gastrointestinal tumor using the tissue cleaning technology (LUCID)
Acronym Validation of a histopathological auto-diagnosis system of gastrointestinal tumor using LUCID
Scientific Title Validation of a novel histopathological auto-diagnosis system of gastrointestinal tumor using the tissue cleaning technology (LUCID)
Scientific Title:Acronym Validation of a histopathological auto-diagnosis system of gastrointestinal tumor using LUCID
Region
Japan

Condition
Condition Gastrointestinal neoplasm
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To validate a novel histopathological auto-diagnosis system of gastrointestinal tumor using the tissue cleaning technology (LUCID)
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Accuracy of histopathological diagnosis
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 underwent surgical resections of gastrointestinal neoplasms at Chiba-Nishi General Hospital from January 2017 to December 2018.
Key exclusion criteria N/A
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Ono
Organization Chiba-Nishi General Hospital
Division name Department of Gastroenterology
Zip code
Address 107-1, Kanegasaku, Matsudo-shi, Chiba.
TEL 047-389-8111
Email satoshi-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Ono
Organization Chiba-Nishi General Hospital
Division name Department of Gastroenterology
Zip code
Address 107-1, Kanegasaku, Matsudo-shi, Chiba.
TEL 047-389-8111
Homepage URL
Email satoshi-tky@umin.ac.jp

Sponsor
Institute Department of Gastroenterology, The University of Tokyo Hospital
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
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
2019 Year 03 Month 01 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 Preinitiation
Date of protocol fixation
2018 Year 12 Month 17 Day
Date of IRB
Anticipated trial start date
2019 Year 04 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 Observation of specimens after tissue cleaning

Management information
Registered date
2019 Year 02 Month 20 Day
Last modified on
2019 Year 02 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040947

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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