UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048015 |
|---|---|
| Receipt number | 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 21:59:08 |
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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
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
d-fuku-k@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University, Department of Gastroenterology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054711
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
