UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048934 |
|---|---|
| Receipt number | R000055753 |
| Scientific Title | Molecular pathological analysis of the occurrence and progress of pancreatic carcinoma in situ using biopsy/pancreatic juice specimen. |
| Date of disclosure of the study information | 2022/09/14 |
| Last modified on | 2022/09/14 14:59:53 |
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Basic information
Public title
Molecular pathological analysis of the occurrence and progress of pancreatic carcinoma in situ using biopsy/pancreatic juice specimen.
Acronym
Analysis of the progress of pancreatic carcinoma in situ.
Scientific Title
Molecular pathological analysis of the occurrence and progress of pancreatic carcinoma in situ using biopsy/pancreatic juice specimen.
Scientific Title:Acronym
Analysis of the progress of pancreatic carcinoma in situ.
Region
| Japan |
Condition
Condition
Pancreatic carcinoma in situ
Small pancreatic ductal adenocarcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Molecular pathological analysis of the occurrence and progress of pancreatic carcinoma in situ using biopsy/pancreatic juice specimen.
Basic objectives2
Others
Basic objectives -Others
Comparison of pancreatic cancer in situ cell and resected pancreas specimen
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Analysis of the molecular pathological factor effecting the progress of pancreatic carcinoma in situ.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with suspicious pancreatic carcinoma in situ and who undergo pancreatic juice cytology.
Key exclusion criteria
cannot obtain consensus.
cannot obtain sufficient pancreatic juice.
cannot undergo surgically resection
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ryota |
| Middle name | |
| Last name | Sagami |
Organization
Oita University Faculty of Medicine
Division name
Department of Gastroenterology
Zip code
879-5593
Address
1-1 Idaigaoka, Hasamacho, Yufu, Oita 8795593, Japan
TEL
097-549-4411
sagami1985@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Ryota |
| Middle name | |
| Last name | Sagami |
Organization
Oita University Faculty of Medicine
Division name
Department of Gastroenterology
Zip code
879-5593
Address
1-1 Idaigaoka, Hasamacho, Yufu, Oita 8795593, Japan
TEL
097-549-4411
Homepage URL
sagami1985@yahoo.co.jp
Sponsor or person
Institute
Oita University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
Oita University Faculty of Medicine
Address
1-1 Idaigaoka, Hasamacho, Yufu, Oita 8795593, Japan
Tel
097-549-4411
sagami1985@yahoo.co.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2340
Org. issuing International ID_1
Oita University Faculty of Medicine
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | Month | 14 | 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
| 2022 | Year | 07 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 25 | Day |
Last follow-up date
| 2027 | Year | 08 | 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
| 2022 | Year | 09 | Month | 14 | Day |
Last modified on
| 2022 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055753
