UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028361 |
|---|---|
| Receipt number | R000032469 |
| Scientific Title | Retrospective investigation of differential features between autoimmune pancreatitis and pancreatic cancer |
| Date of disclosure of the study information | 2017/08/01 |
| Last modified on | 2019/07/24 15:30:55 |
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Basic information
Public title
Retrospective investigation of differential features between autoimmune pancreatitis and pancreatic cancer
Acronym
Retrospective investigation of differential features between AIP and PC
Scientific Title
Retrospective investigation of differential features between autoimmune pancreatitis and pancreatic cancer
Scientific Title:Acronym
Retrospective investigation of differential features between AIP and PC
Region
| Japan |
Condition
Condition
Autoimmune pancreatitis (AIP)
Pancreatic cancer
(PC: as a comparative disease)
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify diagnostically and histopathologically differential features between autoimmune pancreatitis (AIP) and pancreatic cancer (PC) by the retrospective intercomparison.
- Diagnostic findings are based on CT/MRI mainly and others.
- Histopathological findings are delivered from resected specimens.
Basic objectives2
Others
Basic objectives -Others
-
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Diagnostically and histopathologically differential features between AIP and PC
1) Independent evaluation of all imaging data (mainly CT/MRI) and pathological specimens by radiologists and pathologists, respectively, regarding the following items.
--Major evaluation items on diagnostic images--
- General findings
- Findings inside pancreas
- Findings in margin of the lesion
- Findings in pancreatic duct
--Major evaluation items on histopathological findings--
- Findings in pancreas
2) Evaluation of differential features and similarities between AIP and PC by intercomparison based on the consensus between the radiologists and the pathologists.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Pts. diagnosed as AIP or PC
2) Pts. who were performed dynamic MDCT or MRI, followed pancreatic resection within 3 months, during 2005.1 - 2014.12
3) Imaging data of MDCT and/or MRI and histopathological specimens can be provided for central evaluation
4) Diagnostic standard:
AIP: Consensus statement by Deshpande V et al. (Modern Pathology 2012)
PC: Japanese guideline of medical practice for pancreatic cancer 2013
5) Accept regardless of age and
gender
Key exclusion criteria
1) AIP pts. with pre-operative steroid treatment
2) PC pts. with pre-operative
chemotherapy or radiation treatment
3) Pts. who were doubly registered
4) Any other pts. who are determined ineligible for this study by investigators
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Toshifumi |
| Middle name | |
| Last name | Gabata |
Organization
Kanazawa University
Division name
Department of Radiology
Zip code
920-8641
Address
13-1, Takara-machi, Kanazawa, Ishikawa, 920-8641
TEL
+81-76-265-2323
gabata@med.m.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Dai |
| Middle name | |
| Last name | Inoue |
Organization
Kanazawa University Hospital
Division name
Department of Radiology
Zip code
920-8641
Address
13-1, Takara-machi, Kanazawa, Ishikawa, 920-8641
TEL
+81-76-265-2323
Homepage URL
d-inoue@lake.ocn.ne.jp
Sponsor or person
Institute
Department of Radiology,
Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
Bayer Yakuhin Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Independent Ethics Committee of Kanazawa University School of Medicine
Address
13-1, Takara-machi, Kanazawa, Ishikawa
Tel
+81-76-265-2100
t-isomu@adm.kanazawa-u.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
金沢大学大学院医薬保健学総合研究科 内科系医学領域 放射線科学
その他、日本国内およそ10施設が参加予定
About 10 institutions in Japan will participate in this study.
Department of Radiology, Kanazawa University
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 01 | 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
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
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 14 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2019 | Year | 06 | Month | 30 | Day |
Other
Other related information
Observation items
-Patients' background
-Items related to MDCT exam a)
-Items related to MRI exam a)
-Items related to ERCP b)
-Items related to FDG-PET b)
-Items related to EUS-FNA biopsy b)
-Items related to other imaging
exams b)
-Items related to histopathological
Specimens
a) Whichever is mandatory
b) If available
Management information
Registered date
| 2017 | Year | 07 | Month | 25 | Day |
Last modified on
| 2019 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032469
