UMIN-CTR Clinical Trial

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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