UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050758 |
|---|---|
| Receipt number | R000057840 |
| Scientific Title | Development of a Novel Amino Acid PET Probe for Imaging Diagnosis of Early Stage Pancreatic Cancer -Exploratory study of protein expression in pancreatic diseases- |
| Date of disclosure of the study information | 2024/04/04 |
| Last modified on | 2023/04/04 11:44:35 |
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Basic information
Public title
Development of a Novel Amino Acid PET Probe for Imaging Diagnosis of Early Stage Pancreatic Cancer
-Exploratory study of protein expression in pancreatic diseases-
Acronym
Development of an Amino Acid PET Probe for Imaging Diagnosis of Pancreatic Cancer
-Exploratory study of protein expression in pancreatic diseases-
Scientific Title
Development of a Novel Amino Acid PET Probe for Imaging Diagnosis of Early Stage Pancreatic Cancer
-Exploratory study of protein expression in pancreatic diseases-
Scientific Title:Acronym
Development of an Amino Acid PET Probe for Imaging Diagnosis of Pancreatic Cancer
-Exploratory study of protein expression in pancreatic diseases-
Region
| Japan |
Condition
Condition
Pancreatic cancer, and other pancreatic diseases
Classification by specialty
| Hepato-biliary-pancreatic medicine | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Exploratory study of protein expression in pancreatic cancer and other pancreatic diseases using histopathological specimens obtained from patients with pancreatic cancer (including precancerous lesions) and other pancreatic diseases (benign diseases).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of protein expression degrees in benign pancreatic disease, precancerous lesions, and pancreatic cancer lesions
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
About 70 cases of surplus pathology samples of the pancreas removed by surgery and biopsy from patients with pancreatic cancer (including precancerous lesions) or other pancreatic diseases (benign diseases) who obtained comprehensive informed consent at Kanagawa Cancer Center from January 1, 2010 to December 1, 2022, after diagnosis by the Department of Pathology.
Key exclusion criteria
If the research subject or his/her representative refuses the use of the tissue pathology specimen for this research after opting out at National Institutes for Quantum Science and Technology and Kanagawa Cancer Center.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Kana |
| Middle name | |
| Last name | Yamazaki |
Organization
Institute for Quantum Medical Science, Quantum Life and Medical Science Directorate, QST
Division name
Dept. of Molecular Imaging and Theranostics
Zip code
2638555
Address
4-9-1 Anagawa, Inage-ku, Chiba-city, Chiba, Japan
TEL
043-206-3402
yamazkai.kana@qst.go.jp
Public contact
Name of contact person
| 1st name | Kana |
| Middle name | |
| Last name | Yamazaki |
Organization
Institute for Quantum Medical Science, Quantum Life and Medical Science Directorate, QST
Division name
Dept. of Molecular Imaging and Theranostics
Zip code
263-8555
Address
4-9-1 Anagawa, Inage-ku, Chiba-city, Chiba, Japan
TEL
0432063402
Homepage URL
yamazaki.kana@qst.go.jp
Sponsor or person
Institute
Institute for Quantum Medical Science, Quantum Life and Medical Science Directorate, QST
Institute
Department
Personal name
Funding Source
Organization
Institute for Quantum Medical Science, Quantum Life and Medical Science Directorate, QST
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
Certifi ed Review Board, QST
Address
4-9-1 Anagawa, Inage-ku, Chiba-city, Chiba, Japan
Tel
043-206-4706
helsinki@qst.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 04 | 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
70
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 02 | Month | 14 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2023 | Year | 04 | Month | 04 | Day |
Last modified on
| 2023 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057840
| 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 |
