UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043564 |
|---|---|
| Receipt number | R000049749 |
| Scientific Title | Biomarker exploration in patients undergoing boron neutron capture therapy (BNCT) for malignant melanoma and angiosarcoma. |
| Date of disclosure of the study information | 2021/03/10 |
| Last modified on | 2022/10/20 12:25:54 |
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Basic information
Public title
Biomarker exploration in patients undergoing boron neutron capture therapy (BNCT) for malignant melanoma and angiosarcoma.
Acronym
Biomarker exploration in patients undergoing boron neutron capture therapy (BNCT) for malignant melanoma and angiosarcoma.
Scientific Title
Biomarker exploration in patients undergoing boron neutron capture therapy (BNCT) for malignant melanoma and angiosarcoma.
Scientific Title:Acronym
Biomarker exploration in patients undergoing boron neutron capture therapy (BNCT) for malignant melanoma and angiosarcoma.
Region
| Japan |
Condition
Condition
Malignant melanoma of skin and angiosarcoma of skin
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Biomarker analyses are conducted using blood and urine as an accompanying research for patients participating in a clinical trial of boron neutron capture therapy (BNCT) for malignant melanoma and angiosarcoma
Basic objectives2
Others
Basic objectives -Others
Establish a system to measure biomarkers for the efficacy of BNCT
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Analysis of metabolites (including proteins) and genes in peripheral blood and urine to establish a measurement system for biomarkers of BNCT efficacy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Blood and urine sampling
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Primary cutaneous malignant melanoma or angiosarcoma
No evidence of lymph node metastasis or distant metastasis (TNM classification T1-4N0M0 or rT1-4N0M0)
Primary or local recurrence, refusal of surgery or no indication for radical surgery
Refusal of drug therapy or no response to drug therapy (in case of malignant melanoma)
Age between 20 and 85 years on the date of consent.
ECOG performance status score of 0-2
Head and neck, chest, or extremity involvement
Weight less than 95 kg
Key exclusion criteria
Obvious disseminated lesions
The lesion has received radiotherapy in excess of 75 Gy.
Active lesions/active multiple cancers other than the target lesion
Active implantable medical devices such as implantable cardiac pacemakers are implanted
History of BNCT treatment
Target sample size
18
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, 104-0045
TEL
03-3542-2511
hirigaki@ncc.go.jp
Public contact
Name of contact person
| 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, 104-0045
TEL
03-3542-2511
Homepage URL
hirigaki@ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
None
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
Kenkyu Rinri Shinsa Iinkai, National Cancer Center Hospital
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045
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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 03 | Month | 10 | 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
7
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
| 2000 | Year | 01 | Month | 16 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 03 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 04 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 03 | Month | 09 | Day |
Last modified on
| 2022 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049749
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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