UMIN-CTR Clinical Trial

Basic information
Public title	Diagnostic quality of Endoscopic Ultrasound-guided Fine Needle Aspiration for Onco-panel for Geneprofiling of pancreatic cancer - Prospective cohort study -
Acronym	EUS-FNA for Onco-panel for Geneprofiling
Scientific Title	Diagnostic quality of Endoscopic Ultrasound-guided Fine Needle Aspiration for Onco-panel for Geneprofiling of pancreatic cancer - Prospective cohort study -
Scientific Title:Acronym	EUS-FNA for Onco-panel for Geneprofiling
Region	Japan

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

Objectives
Narrative objectives1	To clarify how Onco-panel for Geneprofiling can be evaluated by specimens of EUS-FNA for pancreatic cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Diagnostic sensitivity of Onco-panel for Geneprofiling by specimens of EUS-FNA for pancreatic cancer
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 with unresectable pancreatic cancer diagnosed by imaging and clinically judged to be eligible for Onco-panel for Geneprofiling during the course of chemotherapy
Key exclusion criteria	# Patients who have tendency of bleeding # The lesion cannot be demonstrated # Patients who have the high risk of complication by EUS-FNA # There are some definite vessels between EUS and lesions # The movement by breathing may cause puncture of another organs # Patients who don't understand the aim of this study
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Ichiro Middle name Last name Yasuda
Organization	University of Toyama
Division name	Third Department of Internal Medicine
Zip code	930-0194
Address	2630 Sugitani, Toyama city, Toyama prefecture, Japan
TEL	076-434-7301
Email	yasudaich@gmail.com

Public contact
Name of contact person	1st name Kosuke Middle name Last name Takahashi
Organization	University of Toyama
Division name	Third Department of Internal Medicine
Zip code	930-0194
Address	2630 Sugitani, Toyama city, Toyama prefecture, Japan
TEL	076-434-7301
Homepage URL
Email	takapochi0809@gmail.com

Sponsor
Institute	University of Toyama
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Center for Clinical Reserch in Toyama University Hospital
Address	2630 Sugitani, Toyama city, Toyama prefecture, Japan
Tel	076-415-8857
Email	rinri@adm.u-toyama.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 04 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	Open public recruiting
Date of protocol fixation	2020 Year 01 Month 24 Day
Date of IRB	2020 Year 03 Month 18 Day
Anticipated trial start date	2020 Year 04 Month 06 Day
Last follow-up date	2021 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	We evaluate diagnostic sensitivity of Onco-panel for Geneprofiling by EUS-FNA for pancreatic cancer.

Management information
Registered date	2020 Year 04 Month 07 Day
Last modified on	2020 Year 04 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045720