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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033100
Receipt No. R000037746
Scientific Title VALIDATION OF A NEW CLASSIFICATION FOR IN VIVO DIAGNOSIS OF DUODENAL EPITHELIAL TUMORS WITH CONFOCAL LASER ENDOMICROSCOPY
Date of disclosure of the study information 2018/06/22
Last modified on 2018/06/22

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Basic information
Public title VALIDATION OF A NEW CLASSIFICATION FOR IN VIVO DIAGNOSIS OF DUODENAL EPITHELIAL TUMORS WITH CONFOCAL LASER ENDOMICROSCOPY
Acronym VALIDATION OF DIAGNOSIS OF DUODENAL EPITHELIAL TUMORS WITH CONFOCAL LASER ENDOMICROSCOPY
Scientific Title VALIDATION OF A NEW CLASSIFICATION FOR IN VIVO DIAGNOSIS OF DUODENAL EPITHELIAL TUMORS WITH CONFOCAL LASER ENDOMICROSCOPY
Scientific Title:Acronym VALIDATION OF DIAGNOSIS OF DUODENAL EPITHELIAL TUMORS WITH CONFOCAL LASER ENDOMICROSCOPY
Region
Japan

Condition
Condition superficial non-ampullary duodenal
epithelial tumors (SNADET)
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To establish endoscopic diagnostic algorithm
for SNADET, we developed and validated a new pCLE classification of SNADET
based on the abnormal findings.
Basic objectives2 Others
Basic objectives -Others Time of examination
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The diagnostic yield of pCLE findings by reference to the histopathology of the resected specimen.
Key secondary outcomes N/A

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
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Predilection age, safety
Key exclusion criteria Those who did not approve their study enrollment.
Those who the physician can not guarantee the
safety of endoscopic examination.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomomitsu Tahara
Organization Fujita Health University
Division name Gastroenterology
Zip code
Address 1-98 dengakugakubo kutsukakecyo toyoake
TEL 0562-93-9240
Email shokakan@fujita-hu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomomitsu Tahara
Organization Fujita Health University
Division name Gastroenterology
Zip code
Address 1-98 dengakugakubo kutsukakecyo toyoake
TEL 0562-93-9240
Homepage URL
Email ttahara@fujita-hu.ac.jp

Sponsor
Institute Fujita Health University
Institute
Department

Funding Source
Organization Fujita Health University
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
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
2018 Year 06 Month 22 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 No longer recruiting
Date of protocol fixation
2017 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 05 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 We registered 20 cases.

Management information
Registered date
2018 Year 06 Month 22 Day
Last modified on
2018 Year 06 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037746

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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