UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039779 |
|---|---|
| Receipt number | R000045371 |
| Scientific Title | Establishment the method of surveillance to find early pancreatic cancer for high risk individuals with familial Pancreatic Cancer or hereditary neoplastic syndrome |
| Date of disclosure of the study information | 2020/03/12 |
| Last modified on | 2023/01/21 20:47:17 |
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Basic information
Public title
Establishment the method of surveillance to find early pancreatic cancer for high risk individuals with familial Pancreatic Cancer or hereditary neoplastic syndrome
Acronym
Surveillance for familial Pancreatic Cancer
Scientific Title
Establishment the method of surveillance to find early pancreatic cancer for high risk individuals with familial Pancreatic Cancer or hereditary neoplastic syndrome
Scientific Title:Acronym
DIAMOND study
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
find the early pancreatic cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the population of resecatble pancreatic cancer of pancreatic cancer
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
EUS,MRCP
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
| 50 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Individuals more than 50y with two or more affected blood relatives, with at least one affected FDR.
Individuals more than 50y with BRCA2 orCDKN2A or PALB2,mutation carriers with one affected FDR.
Individuals more than 50y with STK11 or PRSS1 or p16 mutation.
Key exclusion criteria
total gastrectomy
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Susumu |
| Middle name | |
| Last name | Hijioka |
Organization
National Cancer Center
Division name
Department of Hepatobiliary and Pancreatic Oncology
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku Tokyo, Japan
TEL
+81-3-3542-2511
shijioka@ncc.go.jp
Public contact
Name of contact person
| 1st name | SUSUMU |
| Middle name | |
| Last name | HIJIOKA |
Organization
National Cancer Center
Division name
Department of Hepatobiliary and Pancreatic Oncology
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku Tokyo, Japan
TEL
+81-3-3542-2511
Homepage URL
shijioka@ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center Research and Development Fund (2022-A-5).
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center
Address
5-1-1 Tsukiji, Chuo-ku Tokyo, Japan
Tel
+81-3-3542-2511
shijioka@ncc.go.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
54 hospitals
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 12 | 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
| 2019 | Year | 04 | Month | 18 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 18 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 22 | Day |
Last follow-up date
| 2035 | Year | 04 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 03 | Month | 12 | Day |
Last modified on
| 2023 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045371
