UMIN-CTR Clinical Trial

Basic information
Public title	Examination of the usefulness of Maspin staining in EUS-FNA specimens for pancreatic cancer
Acronym	Examination of the usefulness of Maspin staining in EUS-FNA specimens for pancreatic cancer
Scientific Title	Examination of the usefulness of Maspin staining in EUS-FNA specimens for pancreatic cancer
Scientific Title:Acronym	Examination of the usefulness of Maspin staining in EUS-FNA specimens for pancreatic cancer
Region	Japan

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

Objectives
Narrative objectives1	Improvement of pancreatic cancer diagnostic ability
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Sensitivity and specificity of Maspin staining for pancreatic cancer in EUS-FNA specimens.
Key secondary outcomes	Additional effect by performing p53 staining and Maspin staining. Examination of clinicopathological factors of Maspin staining.

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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	People over 20 years old. From April 2015 to December 2017, FNA was performed on a pancreatic mass, and pancreatic cancer was diagnosed. Both Maspin staining and p53 staining were performed, and the prognosis was tracked.
Key exclusion criteria	Cases that are not pancreatic cancer, cases that have not been stained with Maspin or p53 with EUS-FNA, and cases in which the prognosis could not be followed.
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Koh Middle name Last name Fukushi
Organization	Dokkyo Medical University
Division name	Department of Gastroenterology
Zip code	321-0293
Address	880, Kitakobayashi, Mibu, Shimotuga, Tochigi, Japan
TEL	0282-87-2147
Email	d-fuku-k@dokkyomed.ac.jp

Public contact
Name of contact person	1st name Koh Middle name Last name Fukushi
Organization	Dokkyo Medical University
Division name	Department of Gastroenterology
Zip code	321-0293
Address	880, Kitakobayashi, Mibu, Shimotuga, Tochigi, Japan
TEL	0282-87-2147
Homepage URL
Email	d-fuku-k@dokkyomed.ac.jp

Sponsor
Institute	Dokkyo Medical University, Department of Gastroenterology
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	Dokkyo Medical University
Address	Department of Gastroenterology
Tel	0282-87-2147
Email	d-fuku-k@dokkyomed.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 06 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	90
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	No longer recruiting
Date of protocol fixation	2021 Year 08 Month 17 Day
Date of IRB	2021 Year 08 Month 17 Day
Anticipated trial start date	2021 Year 08 Month 17 Day
Last follow-up date	2021 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

From April 2015 to December 2017, of the 130 cases in which EUS-FNA was performed at Dokkyo Medical University Hospital and a definitive diagnosis of pancreatic cancer was obtained, the specimens collected by EUS-FNA were stained with Maspin. , p53 staining was performed in 127 cases, 4 cases for which prognosis could not be followed as of March 2018, and 33 cases with data loss were excluded, and total of 90 cases were included.

Management information
Registered date	2022 Year 06 Month 09 Day
Last modified on	2022 Year 06 Month 09 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054711