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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000048015
Receipt No. R000054711
Scientific Title Examination of the usefulness of Maspin staining in EUS-FNA specimens for pancreatic cancer
Date of disclosure of the study information 2022/06/15
Last modified on 2022/06/09

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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