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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000039581
Receipt No. R000044084
Scientific Title Utility of DFI-EUS for differential diagnosis in pancreatic tumors.
Date of disclosure of the study information 2021/01/01
Last modified on 2020/02/24

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Basic information
Public title Utility of DFI-EUS for differential diagnosis in pancreatic tumors.
Acronym DFI-EUS for pancreatic tumors
Scientific Title Utility of DFI-EUS for differential diagnosis in pancreatic tumors.
Scientific Title:Acronym DFI-EUS for pancreatic tumors
Region
Japan

Condition
Condition pancreatic tumors
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Utility of DFI-EUS for the differential diagnosis of SMT
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To evaluate the utility of DFI-EUS for the differential diagnosis of pancreatic tumors
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who were diagnosed or suspected pancreatic lesion with imaging modalities
Key exclusion criteria Patients who could not undergo EUS
Target sample size 450

Research contact person
Name of lead principal investigator
1st name kitano
Middle name
Last name Masayuki
Organization Wakayama Medical University
Division name Second Department of Internal Medicine
Zip code 641-0012
Address 811-1, Kimiidera, Wakayama City, Wakayama, Japan
TEL 073-447-2300
Email kitano@wakayama-med.ac.jp

Public contact
Name of contact person
1st name Yamashita
Middle name
Last name Yasunobu
Organization Wakayama Medical University
Division name Second Department of Internal Medicine
Zip code 641-0012
Address 811-1, Kimiidera, Wakayama City, Wakayama, Japan
TEL 073-447-2300
Homepage URL
Email yasunobu@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University
Institute
Department

Funding Source
Organization Wakayama Medical University
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Wakayama Medical University
Address 811-1, Kimiidera, Wakayama City, Wakayama
Tel 073-447-2300/ (+81)-73-4472300
Email waidai@wakayama-med.ac.jp

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
2021 Year 01 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 Enrolling by invitation
Date of protocol fixation
2018 Year 12 Month 25 Day
Date of IRB
2018 Year 12 Month 25 Day
Anticipated trial start date
2019 Year 01 Month 01 Day
Last follow-up date
2023 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Wakayama Medical University

Management information
Registered date
2020 Year 02 Month 24 Day
Last modified on
2020 Year 02 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044084

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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