UMIN-CTR Clinical Trial

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
Email	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
Email	d-inoue@lake.ocn.ne.jp

Sponsor
Institute	Department of Radiology, Kanazawa University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032469