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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000042618
Receipt No. R000048635
Scientific Title The usefulness of screening with direct forward viewing radial EUS and MRI for high risk individual with family history of pancreatic cancer and hereditary pancreatic cancer syndrome.
Date of disclosure of the study information 2020/12/01
Last modified on 2020/12/01

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Basic information
Public title The usefulness of screening with direct forward viewing radial EUS and MRI for high risk individual with family history of pancreatic cancer and hereditary pancreatic cancer syndrome.
Acronym Screening for HRI with family history of PC
Scientific Title The usefulness of screening with direct forward viewing radial EUS and MRI for high risk individual with family history of pancreatic cancer and hereditary pancreatic cancer syndrome.
Scientific Title:Acronym Screening for HRI with family history of PC
Region
Japan

Condition
Condition Pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 examine the frequency of pancreatic cancer and pancreatic cancer high risk factors such as pancreatic cyst, main pancreatic duct dilation, and early chronic pancreatitis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incidence of pancreatic diseases such as pancreatic cancer and pancreatic endocrine tumors
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
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1)Individuals with at least one affected first degree relative(FDR)

2)Individuals with Hereditary pancreatitis (HP), Hereditary breast ovarian cancer syndrome (HBOC), Peutz-Jeghers syndrome,Familial atypical multiple melanoma (FAMMM), Fereditary nonpolyposis colon cancer (HNPCC), familial adenomatous polyposis (FAP)
Key exclusion criteria Cases who cannot receive planned test(ex.
total gastrectomy, Claustrophobia)
Target sample size 360

Research contact person
Name of lead principal investigator
1st name Reiko
Middle name
Last name Ashida
Organization Wakayama Medical University
Division name Second Department of Internal Medicine
Zip code 641-8509
Address 811-1 Kimiidera, Wakayama City
TEL 073-447-2300
Email rashida@wakayama-med.ac.jp

Public contact
Name of contact person
1st name Naho
Middle name
Last name Maeda
Organization Wakayama Medical University
Division name Second Department of Internal Medicine
Zip code 641-8509
Address 811-1 Kimiidera, Wakayama City
TEL 073-447-2300
Homepage URL
Email ninai@wakayama-med.acj.jp

Sponsor
Institute Wakayama Medical University
Institute
Department

Funding Source
Organization none
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 Research Ethics Committee of Wakayama Medical University
Address 811-1 Kimiidera, Wakayama, Wakayama Prefecture
Tel 073-447-2300/+81-73-447-2300
Email wa-rinri@wakayama-med.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
2020 Year 12 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 Open public recruiting
Date of protocol fixation
2020 Year 10 Month 08 Day
Date of IRB
2020 Year 10 Month 08 Day
Anticipated trial start date
2020 Year 12 Month 01 Day
Last follow-up date
2030 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2020 Year 12 Month 01 Day
Last modified on
2020 Year 12 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048635

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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