UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054458 |
|---|---|
| Receipt number | R000062202 |
| Scientific Title | Protein expression analysis after heavy ion radiotherapy in pancreatic cancer specimens |
| Date of disclosure of the study information | 2024/05/27 |
| Last modified on | 2024/11/21 09:09:22 |
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Basic information
Public title
Protein expression analysis in pancreatic cancer specimens
Acronym
Pancreatic cancer expression analysis
Scientific Title
Protein expression analysis after heavy ion radiotherapy in pancreatic cancer specimens
Scientific Title:Acronym
Heavy ion radiotherapy pancreatic cancer expression analysis
Region
| Japan |
Condition
Condition
Pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The protein expression analysis in pancreatic cancer samples after heavy ion beam irradiation will be conducted to evaluate whether the protein analyzed in this study is effective as a therapeutic target molecule.
Basic objectives2
Others
Basic objectives -Others
Protein expression analysis in pancreatic cancer specimens
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Expression pattern of target protein in pancreatic cancer specimens after heavy ion radiotherapy
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
Patients with remaining pathological tissue specimens removed during surgery from pancreatic cancer patients for whom surgery was indicated after heavy ion radiotherapy
Key exclusion criteria
Patients whose research subjects or their representatives have refused the use of pathological tissue specimens for this research
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | TSUJI |
Organization
National Institutes for Quantum Science and Technology
Division name
Department of Molecular Imaging and Theranostics, Institute for Quantum Medical Science
Zip code
263-8555
Address
4-9-1 Anagawa, Inage, Chiba
TEL
043-382-3704
tsuji.atsushi@qst.go.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | TSUJI |
Organization
National Institutes for Quantum Science and Technology
Division name
Department of Molecular Imaging and Theranostics, Institute for Quantum Medical Science
Zip code
263-8555
Address
4-9-1 Anagawa, Inage, Chiba
TEL
043-382-3704
Homepage URL
https://www.nirs.qst.go.jp/research/review/ethical_research_list.html
tsuji.atsushi@qst.go.jp
Sponsor or person
Institute
National Institutes for Quantum Science and Technology
Institute
Department
Personal name
Funding Source
Organization
MEXT(Japan)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Dokkyo Medical University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Institutes for Quantum Science and Technology Clinical Research Review Committee
Address
4-9-1 Anagawa, Inage, Chiba
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
国立研究開発法人 量子科学技術研究開発機構（千葉県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | Month | 27 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 05 | Month | 16 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will examine the expression intensity of TNC protein by immunohistochemical staining of pancreatic histopathological specimens obtained from pancreatic cancer patients, and evaluate whether it is suitable as a target molecule for additional treatment after heavy ion radiotherapy. The specimen will also be stained with hematoxylin and eosin, and the tissue type will be confirmed. Immunohistochemical staining of the target molecule of the PET probe will also be performed to obtain information for selecting a suitable PET probe.
Management information
Registered date
| 2024 | Year | 05 | Month | 22 | Day |
Last modified on
| 2024 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062202
