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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | pancreatic cancer | |
Classification by specialty |
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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 | |
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Purpose of intervention | |
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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 |
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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 | |
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 |
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 |
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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 |
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Anticipated trial start date |
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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 |
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Last modified on |
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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 |