UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028714
Receipt number 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 2020/02/18 09:33:42

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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 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 or person

Institute

First Department of Internal Medicine, Gifu University Hospital

Institute

Department

Personal name



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

Value
https://center6.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