UMIN-CTR Clinical Trial

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 Takuji Middle name Last name Iwashita
Organization	Gifu University Hospital
Division name	First Department of Internal Medicine
Zip code	501-1194
Address	1-1 Yanagido, Gifu
TEL	058-230-6308
Email	takuji@w7.dion.ne.jp

Public contact
Name of contact person	1st name Takuji Middle name Last name Iwashita
Organization	Gifu University Hospital
Division name	First Department of Internal Medicine
Zip code	501-1194
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	the IRB of Gifu University Hospital
Address	1-1 Yanagido, Gifu, Japan
Tel	058-230-6059
Email	rinri@gifu-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	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	2017 Year 07 Month 05 Day
Anticipated trial start date	2017 Year 09 Month 01 Day
Last follow-up date	2022 Year 07 Month 05 Day
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	2020 Year 02 Month 18 Day

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