UMIN-CTR Clinical Trial

Basic information
Public title	Utility of Endoscopic Ultrasound-Guided Tissue Acquisition for Precision Medicine -Multicenter Prospective Cohort Study-
Acronym	EUS-TA for Precision Medicine of PDAC
Scientific Title	Utility of Endoscopic Ultrasound-Guided Tissue Acquisition for Precision Medicine -Multicenter Prospective Cohort Study-
Scientific Title:Acronym	EUS-TA for Precision Medicine of PDAC
Region	Japan

Condition
Condition	Pancreatic Cancer
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To clarify the success rate of multi gene panel using EUS-FNA samples for precision medicine
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Success rate of multi gene panel using EUS-FNA specimens
Key secondary outcomes	Patient background factors and procedure factors involved in the success of multi gene panel using EUS-FNA specimens

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	1. 20 years old and over 2. Cases that have been pathologically diagnosed as unresectable pancreatic malignant tumor 3. Cases scheduled to undergo cancer genome testing using EUS-FNA specimens 4. Patients who have received sufficient explanation about participation in the study, and after sufficient understanding, have obtained written consent by the patient's free will.
Key exclusion criteria	1. Cases who are thought to be ineligible for this study
Target sample size	50

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, Wakayama, Japan
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, Wakayama, Japan
TEL	073-447-2300
Homepage URL
Email	ninai@wakayama-med.ac.jp

Sponsor
Institute	Wakayama Medical University
Institute
Department

Funding Source
Organization	Medico's Hirata Inc.
Organization
Division
Category of Funding Organization	Profit organization
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 641-8509, Japan
Tel	073-447-2300
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	2022 Year 03 Month 15 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 12 Month 20 Day
Date of IRB	2022 Year 01 Month 24 Day
Anticipated trial start date	2022 Year 04 Month 01 Day
Last follow-up date	2023 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Research method 1.Enroll the patient with consent in the study. 2.Register patient background factors and procedure factors when collecting EUS-FNA samples used for multi-gene panel testing. 3.Confirm with the pathologist whether the EUS-FNA sample is sufficient for the multi-gene panel test. 4.Submit the EUS-FNA sample to the multi-gene panel test. 5.Register the results of the multi-gene panel test and the results of the expert panel. Observation/ evaluation 1.Survey items before entry of the study Patient background factors and past history, age, gender, pancreatic cancer stage, treatment history 2.Survey items after entry of the study Patient background factors at the time of sample collection, procedure factors, amount of collected DNA, results of oncogene panel test

Management information
Registered date	2022 Year 03 Month 14 Day
Last modified on	2022 Year 03 Month 14 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053804