UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017843 |
|---|---|
| Receipt number | R000020674 |
| Scientific Title | Development of photodynamic diagnosis and photodynamic therapy using 5-aminolevulinic acid for bone and soft tissue tumors. |
| Date of disclosure of the study information | 2015/07/01 |
| Last modified on | 2015/06/09 15:58:37 |
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Basic information
Public title
Development of photodynamic diagnosis and photodynamic therapy using 5-aminolevulinic acid for bone and soft tissue tumors.
Acronym
Development of photodynamic therapy for bone and soft tissue tumors.
Scientific Title
Development of photodynamic diagnosis and photodynamic therapy using 5-aminolevulinic acid for bone and soft tissue tumors.
Scientific Title:Acronym
Development of photodynamic therapy for bone and soft tissue tumors.
Region
| Japan |
Condition
Condition
one and soft tissue tumors
Classification by specialty
| Orthopedics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Development of photodynamic diagnosis and photodynamic therapy using 5-aminolevulinic acid for bone and soft tissue tumors.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Recurrence rate
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
Treatment
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
Internal use of 5-aminolevulinic acid
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Diagnosis of bone and soft tissue tumor
Key exclusion criteria
No-consent
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuo Yazawa |
Organization
Saitama Medical University International Medical Center
Division name
Bone and soft tissue oncology
Zip code
Address
Saitamaken hidakashi yamane 1397-1
TEL
042-984-4111
yyazawa@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taketo Okubo |
Organization
Saitama Medical University International Medical Center
Division name
Bone and soft tissue oncology
Zip code
Address
Saitamaken hidakashi yamane 1397-1
TEL
042-984-4111
Homepage URL
tohkubo@juntendo.ac.jp
Sponsor or person
Institute
Bone and soft tissue oncology, Saitama Medical University International Medical Center
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University International Medical Center
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
Address
Tel
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
| 2015 | Year | 07 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 09 | Day |
Last modified on
| 2015 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020674
| 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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| Registered date | File name |
