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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000043564
Receipt No. 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 2021/09/08

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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
Email 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
Email hirigaki@ncc.go.jp

Sponsor
Institute National Cancer Center
Institute
Department

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
Email 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
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 Enrolling by invitation
Date of protocol fixation
2000 Year 01 Month 16 Day
Date of IRB
2000 Year 02 Month 03 Day
Anticipated trial start date
2000 Year 02 Month 04 Day
Last follow-up date
2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2022 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2021 Year 03 Month 09 Day
Last modified on
2021 Year 09 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049749

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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