UMIN-CTR Clinical Trial

Basic information
Public title	Development of rapid on site cytologic evaluation using artificial intelligence (AI-ROSE) during EUS-FNA
Acronym	AI-ROSE
Scientific Title	Development of rapid on site cytologic evaluation using artificial intelligence (AI-ROSE) during EUS-FNA
Scientific Title:Acronym	AI-ROSE
Region	Japan

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

Objectives
Narrative objectives1	To examine the usefulness of diagnosis using artificial intelligence (AI) in ROSE by an endoscopist during EUS-FNA
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Diagnostic ability in ROSE during EUS-FNA for pancreatic tumor using AI
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	90 years-old >
Gender	Male and Female
Key inclusion criteria	1) Patients with a solid pancreatic mass who underwent ROSE during EUS-FNA and have a preparatory structure capable of pathological cytology. 2) Cases with a definitive diagnosis of pancreatitis or pancreatic cancer
Key exclusion criteria	Cases without ROSE during EUS-FNA
Target sample size	200

Research contact person
Name of lead principal investigator	1st name REIKO Middle name Last name ASHIDA
Organization	Wakayama Medical University
Division name	Second Department of Internal Medicine
Zip code	641-8509
Address	811-1 Kimiidera, Wakayama City
TEL	073-447-2300
Email	rashida@wakayama-med.ac.jp

Public contact
Name of contact person	1st name REIKO Middle name Last name ASHIDA
Organization	Wakayama Medical University
Division name	Second Department of Internal Medicine
Zip code	641-8509
Address	811-1 Kimiidera, Wakayama City
TEL	073-441-0627
Homepage URL
Email	ninai@wakayama-med.acj.jp

Sponsor
Institute	Wakayama Medical University
Institute
Department

Funding Source
Organization	Self funding
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	Research Ethics Committee of Wakayama Medical University
Address	811-1 Kimiidera, Wakayama, Wakayama Prefecture
Tel	+81-73-447-2300(3692)
Email	wa-rinri@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	2020 Year 10 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	Open public recruiting
Date of protocol fixation	2020 Year 07 Month 17 Day
Date of IRB	2020 Year 09 Month 08 Day
Anticipated trial start date	2020 Year 09 Month 08 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	opt-out

Management information
Registered date	2020 Year 10 Month 22 Day
Last modified on	2020 Year 10 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048186