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
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
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
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
