UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037295 |
|---|---|
| Receipt number | R000042419 |
| Scientific Title | Exploratory study for detecting risk factors of pancreatic tumors including pancreatic cancers |
| Date of disclosure of the study information | 2019/09/01 |
| Last modified on | 2023/04/11 07:02:19 |
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Basic information
Public title
Exploratory study for detecting risk factors of pancreatic tumors including pancreatic cancers
Acronym
Exploratory study of pancreatic tumor
Scientific Title
Exploratory study for detecting risk factors of pancreatic tumors including pancreatic cancers
Scientific Title:Acronym
Exploratory study of pancreatic tumor
Region
| Japan |
Condition
Condition
pancreatic cancer, pancreatic neuroendocrine neoplasm, intraductal papillary mutinous neoplasm, pancreatic cycles neoplasm, chronic pancreatitis
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
It is known that there are many risk factors for pancreatic cancers, including not only the environmental factors such as smoking or drinking habits, but also the genetic factors, however, we cannot understand the mechanism of pancreatic cancer. So, we want to reveal the risk factors for pancreatic cancer by analyzing clinicopathological and genetic factors for pancreatic cancers and the other pancreatic tumors, along with environmental factors.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Discovery for risk factors of pancreatic cancers and the other pancreatic tumors
Key secondary outcomes
(1) Correlation between pathological features and prognosis for familial pancreatic cancer
(3) Detection for epidemiological factors which correlate with recurrence and occurrence of the other type of cancers
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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Patients who were diagnosed as pancreatic cancers or the other pancreatic tumors
(2) Patients or their representatives who agreed with this study by documents
Key exclusion criteria
(1) Patients who disagreed with this study
(2) Minors
(3) Patients whom we judged not appropriate for this study
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Minoru |
| Middle name | |
| Last name | Kitago |
Organization
Keio University School of Medicine
Division name
Department of Surgery (General and Gastroenterology)
Zip code
1608582
Address
Shinanomachi 35, Shinjuku-ku, Tokyo
TEL
0353633802
dragonpegasus@keio.jp
Public contact
Name of contact person
| 1st name | Kodai |
| Middle name | |
| Last name | Abe |
Organization
Keio University School of Medicine
Division name
Department of Surgery (General and Gastroenterology)
Zip code
1608582
Address
Shinanomachi 35, Shinjuku-ku, Tokyo
TEL
0353633802
Homepage URL
08medrfcab@keio.jp
Sponsor or person
Institute
Keio University School of Medicine Department of Surgery
Institute
Department
Personal name
Funding Source
Organization
self
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Institutional Review Board
Address
Shinanomachi 35, Shinjuku-ku, Tokyo
Tel
03-5363-3961
med-rinri-jimu@adst.keio.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
| 2019 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1111/cas.15316
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
| 2022 | Year | 04 | Month | 01 | Day |
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 | 07 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 30 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
DNA analysis
Management information
Registered date
| 2019 | Year | 07 | Month | 06 | Day |
Last modified on
| 2023 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042419
| Research Plan | |
|---|---|
| Registered date | File name |
| 2020/07/06 | 膵癌探索的研究.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
