UMIN-CTR Clinical Trial

Basic information
Public title	The role of TP53 gene analysis in EUS-guided FNA specimens for differential diagnosis of pancreatic ductal adenocarcinoma
Acronym	TP53 gene analysis in pancreatic ductal adenocarcinoma
Scientific Title	The role of TP53 gene analysis in EUS-guided FNA specimens for differential diagnosis of pancreatic ductal adenocarcinoma
Scientific Title:Acronym	TP53 gene analysis in pancreatic ductal adenocarcinoma
Region	Japan North America

Condition
Condition	pancreatic solid mass
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To evaluate the usefulness of TP53 gene analysis in EUS-guided FNA specimens from pancreatic masses.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Improvement of the diagnostic accuracy by TP53 gene analysis in EUS-guided FNA specimens from pancreatic solid masses
Key secondary outcomes	Development of predictive factors in therapeutics

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
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Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who underwent EUS-guided FNA of pancreatic masses.
Key exclusion criteria	Case whom no consent is obtained.
Target sample size	160

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yasuki Hori
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Gastroenterology and Metabolism
Zip code
Address	1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan
TEL	+81-52-853-8211
Email	yhori@med.nagoya-cu.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Yasuki Hori
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Gastroenterology and Metabolism
Zip code
Address	1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya Japan
TEL	+81-52-853-8211
Homepage URL
Email	yhori@med.nagoya-cu.ac.jp

Sponsor
Institute	Nagoya City University Graduate School of Medical Sciences
Institute
Department

Funding Source
Organization	Pancreas Research Foundation of Japan
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

Other related organizations
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IRB Contact (For public release)
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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	名古屋市立大学病院（愛知県）

Other administrative information
Date of disclosure of the study information	2015 Year 12 Month 20 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
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Results
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Baseline Characteristics
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Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 12 Month 20 Day
Date of IRB	2015 Year 12 Month 20 Day
Anticipated trial start date	2016 Year 01 Month 01 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry	2017 Year 03 Month 31 Day
Date trial data considered complete	2017 Year 03 Month 31 Day
Date analysis concluded	2018 Year 08 Month 01 Day

Other
Other related information	Samples are collected from subjects who participated in this study in Nagoya City University Hospital and research affiliated facilities. Samples and clinical information without containing personal information are numbered and managed in Nagoya City University Hospital.

Management information
Registered date	2015 Year 12 Month 20 Day
Last modified on	2020 Year 02 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023418