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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000039623
Receipt No. R000045193
Scientific Title Clinical study to detect the feature of imaging modalities for the early detection of pancreatic cancer
Date of disclosure of the study information 2020/03/01
Last modified on 2020/04/27

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Basic information
Public title Evalutation of the patients with localized stricture of MPD without obvious mass in the pancreas
Acronym Pancreatic cancer study
Scientific Title Clinical study to detect the feature of imaging modalities for the early detection of pancreatic cancer
Scientific Title:Acronym Study for the early detection of pancreatic cancer
Region
Japan

Condition
Condition Patients with localized MPD stricture without obvious mass in pancreas
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to find new imaging findings leading to the early detection of pancreatic cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Reading computed tomography, magnetic resonance imaging, and endoscopic ultrasonography image.
Key secondary outcomes

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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with MPD stricture
Key exclusion criteria Patients with obvious pancreatic mass
Patients with chronic pancreatitis
Patients with post pancreatic surgery
Patients with pancreatic injury
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Akira
Middle name
Last name Kurita
Organization Kitano Hospital, Tazuke Kofukai Medical Research Institute.
Division name Department of Gastroenterology and Hepatology
Zip code 530-8480
Address 2-4-20 Ohgimachi, Kita-ku, Osaka 530-8480, Japan.
TEL 06-6131-2662
Email kuritaaki1976@gmail.com

Public contact
Name of contact person
1st name Akira
Middle name
Last name Kurita
Organization Kitano Hospital, Tazuke Kofukai Medical Research Institute.
Division name Department of Gastroenterology and Hepatology
Zip code 530-8480
Address 2-4-20 Ohgimachi, Kita-ku, Osaka, Japan
TEL 06-6131-2662
Homepage URL
Email kuritaaki1976@gmail.com

Sponsor
Institute Kitano Hospital, Tazuke Kofukai Medical Research Institute.
Institute
Department

Funding Source
Organization Kitano Hospital, Tazuke Kofukai Medical Research Institute.
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Medical Ethics Committee of Kitano Hospital
Address 2-4-20 Ohgimachi, Kita-ku, Osaka, Japan
Tel 06-6131-2662
Email rinshou@kitano-hp.or.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 公益財団法人田附興風会医学研究所北野病院

Other administrative information
Date of disclosure of the study information
2020 Year 03 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 Enrolling by invitation
Date of protocol fixation
2013 Year 01 Month 01 Day
Date of IRB
2018 Year 08 Month 01 Day
Anticipated trial start date
2013 Year 01 Month 01 Day
Last follow-up date
2020 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Retrospective analysis

Management information
Registered date
2020 Year 02 Month 28 Day
Last modified on
2020 Year 04 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045193

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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