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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032469


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name