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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044462
Receipt No. R000050795
Scientific Title Development of cytological analysis of pancreatic cancer using homology technology
Date of disclosure of the study information 2021/06/10
Last modified on 2021/06/07

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Basic information
Public title Development of cytological analysis of pancreatic cancer using homology technology
Acronym Development of cytological analysis of pancreatic cancer using homology technology
Scientific Title Development of cytological analysis of pancreatic cancer using homology technology
Scientific Title:Acronym Development of cytological analysis of pancreatic cancer using homology technology
Region
Japan

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

Objectives
Narrative objectives1 Currently, medical image analysis research using artificial intelligence (AI) has been active. However, for randomly deformed lesions, systems using educational algorithms have major barriers to practical use, such as price, calculation time, and black boxing of algorithms. Especially in cytology, it is necessary to capture and analyze the random and three-dimensional distribution of lesions, which is extremely difficult to put into practical use.
Therefore, we will analyze the cytological image of pancreatic cancer using a new mathematical method, "homology profile method", and examine its effectiveness for cytology of pancreatic cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The sensitivity, specificity, and correct diagnosis rate of the homology profile method are calculated by comparing the analysis results of each sample by the homology profile method with the final pathological 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 1) Patients who underwent EUS-FNA and underwent cytology
2) Patients whose background can be confirmed in medical records
Key exclusion criteria Cases that the principal investigator / coordinator deems inappropriate for inclusion in the study
Target sample size 180

Research contact person
Name of lead principal investigator
1st name Reiko
Middle name
Last name Yamada
Organization Mie University
Division name Gastroenterology and Hepatology
Zip code 514-8507
Address 2-174, Edobashi, Tsu-city, Mie-prefecture
TEL 059(232)1111
Email reiko-t@med.mie-u.ac.jp

Public contact
Name of contact person
1st name Reiko
Middle name
Last name Yamada
Organization Mie University Hospital
Division name Gastroenterology and Hepatology
Zip code 514-8507
Address 2-174, Edobashi, Tsu-city, Mie-prefecture
TEL 059(232)1111
Homepage URL
Email reiko-t@med.mie-u.ac.jp

Sponsor
Institute Mie University
Institute
Department

Funding Source
Organization Mie University
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Mie University
Address 2-174, Edobashi, Tsu-city, Mie-prefecture
Tel 059(232)1111
Email reiko-t@med.mie-u.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 06 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 Preinitiation
Date of protocol fixation
2021 Year 06 Month 10 Day
Date of IRB
Anticipated trial start date
2021 Year 06 Month 10 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observation items and contents to be collected
#Patient information (presence or absence of pancreatic cancer, final diagnosis, gender, age, stage for pancreatic cancer)
#Histopathological examination (microscopic image of cytological preparation)

Management information
Registered date
2021 Year 06 Month 07 Day
Last modified on
2021 Year 06 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050795

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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