UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050486 |
|---|---|
| Receipt number | R000057509 |
| Scientific Title | Biomarker exploration in patients undergoing boron neutron capture therapy (BNCT). |
| Date of disclosure of the study information | 2023/03/20 |
| Last modified on | 2024/03/05 17:30:00 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Biomarker exploration in patients undergoing boron neutron capture therapy (BNCT).
Acronym
Biomarker exploration in patients undergoing boron neutron capture therapy (BNCT).
Scientific Title
Biomarker exploration in patients undergoing boron neutron capture therapy (BNCT).
Scientific Title:Acronym
Biomarker exploration in patients undergoing boron neutron capture therapy (BNCT).
Region
| Japan |
Condition
Condition
Cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Biomarker analysis using blood and urine samples will be performed on patients undergoing boron neutron capture therapy (BNCT) at National Cancer Center Hospital.
Basic objectives2
Others
Basic objectives -Others
To investigate the mechanism of tumor resistance acquisition after BNCT.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
metabolome analysis, proteome analysis, comprehensive analysis of tumor gene aberrations and gene expression aberrations, comprehensive gene expression analysis of tumor-infiltrating immune cells, protein expression analysis of tumor-infiltrating immune cells, LAT-1 expression analysis
Key secondary outcomes
Correlations between clinical information and pharmacokinetics and the primary endpoints will be examined.
Base
Study type
Others,meta-analysis etc
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 who received BNCT at National Cancer Center Hospital and gave consent to participate in this study.
Key exclusion criteria
Patients for whom the necessary samples for analysis could not be obtained.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Igaki |
Organization
National Cancer Center Hospital
Division name
Department of Radiation Oncology
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
hirigaki@ncc.go.jp
Public contact
Name of contact person
| 1st name | Tairo |
| Middle name | |
| Last name | Kashihara |
Organization
National Cancer Center Hospital
Division name
Department of Radiation Oncology
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
Homepage URL
tkashiha@ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Hiroshi IGAKI
Funding Source
Organization
Japan Agency for Medical Research and Development
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
Ethics Review Board of National Cancer Center
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
Tel
03-3542-2511
irst@ml.res.ncc.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
国立がん研究センター中央病院
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 20 | 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
| 2023 | Year | 01 | Month | 04 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 06 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 07 | Day |
Last follow-up date
| 2028 | 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
| 2023 | Year | 03 | Month | 03 | Day |
Last modified on
| 2024 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057509
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
