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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028714
Receipt No. R000032848
Scientific Title Project for Detection of Early Pancreatic Cancer in Gifu Multi-center prospective cohort study
Date of disclosure of the study information 2017/09/01
Last modified on 2017/08/17

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Basic information
Public title Project for Detection of Early Pancreatic Cancer in Gifu Multi-center prospective cohort study
Acronym DEEP project
Scientific Title Project for Detection of Early Pancreatic Cancer in Gifu Multi-center prospective cohort study
Scientific Title:Acronym DEEP project
Region
Japan Asia(except Japan)

Condition
Condition pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To detect early pancreatic cancer by following up high-risk cohort of pancreatic cancer

To explore an effective method to diagnose early pancreatic cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Association between high risk cohort for pancreatic cancer and actual incidence of pancreatic cancer
Key secondary outcomes Effective diagnostic method of pancreatic cancer
Effective surveillance method of pancreatic cancer

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

Not applicable
Gender Male and Female
Key inclusion criteria 1. patients with risk factors for pancreatic cancer
-family history
-hereditary diseases
-pancreatic mucinous cysts
-chronic pancreatitis
2. patients with h/o surgery for pancreatic cancer
3. patients with consequential findings of pancreatic cancer, such as dilated MPD, deterioration of diabetics mellitus, elevation of tumor marker or pancreatic enzymes.
Key exclusion criteria 1. patients under 20 years of age
2. patients with having treatment for malignant diseases
3. patients cannot provide written informed consent
4. patients whom physicians considers as inappropriate for participating this study
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takuji Iwashita
Organization Gifu University Hospital
Division name First Department of Internal Medicine
Zip code
Address 1-1 Yanagido, Gifu
TEL 058-230-6308
Email takuji@w7.dion.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takuji Iwashita
Organization Gifu University Hospital
Division name First Department of Internal Medicine
Zip code
Address 1-1 Yanagido, Gifu
TEL 058-230-6308
Homepage URL
Email takuji@w7.dion.ne.jp

Sponsor
Institute First Department of Internal Medicine, Gifu University Hospital
Institute
Department

Funding Source
Organization NA
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
Address
Tel
Email

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 岐阜市民病院/ Gifu Municipal Hospital
岐阜県総合医療センター/ Gifu Prefectural General Medical Center

Other administrative information
Date of disclosure of the study information
2017 Year 09 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
2017 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information NA

Management information
Registered date
2017 Year 08 Month 17 Day
Last modified on
2017 Year 08 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032848

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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