UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042618 |
|---|---|
| Receipt number | R000048635 |
| Scientific Title | The usefulness of screening with direct forward viewing radial EUS and MRI for high risk individual with family history of pancreatic cancer and hereditary pancreatic cancer syndrome. |
| Date of disclosure of the study information | 2020/12/01 |
| Last modified on | 2020/12/01 21:00:26 |
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Basic information
Public title
The usefulness of screening with direct forward viewing radial EUS and MRI for high risk individual with family history of pancreatic cancer and hereditary pancreatic cancer syndrome.
Acronym
Screening for HRI with family history of PC
Scientific Title
The usefulness of screening with direct forward viewing radial EUS and MRI for high risk individual with family history of pancreatic cancer and hereditary pancreatic cancer syndrome.
Scientific Title:Acronym
Screening for HRI with family history of PC
Region
| Japan |
Condition
Condition
Pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
examine the frequency of pancreatic cancer and pancreatic cancer high risk factors such as pancreatic cyst, main pancreatic duct dilation, and early chronic pancreatitis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of pancreatic diseases such as pancreatic cancer and pancreatic endocrine tumors
Key secondary outcomes
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Individuals with at least one affected first degree relative(FDR)
2)Individuals with Hereditary pancreatitis (HP), Hereditary breast ovarian cancer syndrome (HBOC), Peutz-Jeghers syndrome,Familial atypical multiple melanoma (FAMMM), Fereditary nonpolyposis colon cancer (HNPCC), familial adenomatous polyposis (FAP)
Key exclusion criteria
Cases who cannot receive planned test(ex.
total gastrectomy, Claustrophobia)
Target sample size
360
Research contact person
Name of lead principal investigator
| 1st name | Reiko |
| Middle name | |
| Last name | Ashida |
Organization
Wakayama Medical University
Division name
Second Department of Internal Medicine
Zip code
641-8509
Address
811-1 Kimiidera, Wakayama City
TEL
073-447-2300
rashida@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Naho |
| Middle name | |
| Last name | Maeda |
Organization
Wakayama Medical University
Division name
Second Department of Internal Medicine
Zip code
641-8509
Address
811-1 Kimiidera, Wakayama City
TEL
073-447-2300
Homepage URL
ninai@wakayama-med.acj.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
none
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
Research Ethics Committee of Wakayama Medical University
Address
811-1 Kimiidera, Wakayama, Wakayama Prefecture
Tel
073-447-2300/+81-73-447-2300
wa-rinri@wakayama-med.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | 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
| 2020 | Year | 10 | Month | 08 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 08 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2020 | Year | 12 | Month | 01 | Day |
Last modified on
| 2020 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048635
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
