UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020612 |
|---|---|
| Receipt number | R000023615 |
| Scientific Title | Efficacy of conchotome muscle biopsy |
| Date of disclosure of the study information | 2016/02/01 |
| Last modified on | 2023/03/20 14:58:02 |
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Basic information
Public title
Efficacy of conchotome muscle biopsy
Acronym
Efficacy of conchotome muscle biopsy
Scientific Title
Efficacy of conchotome muscle biopsy
Scientific Title:Acronym
Efficacy of conchotome muscle biopsy
Region
| Japan |
Condition
Condition
cases who need muscle biopsy
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate diagnostic performance and safety of conchotome muscle biopsy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
efficiency of conchotome muslce biopsy for diagnosis of myopathy
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
to employ conchotome muscle biopsy, once
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
| 13 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.patients who need muscle biopsy for the diagnosis of polymyositis/dermatomyositis
2.patients who need muscle biopsy for the diagnosis of myopathy other than polymyositis/dermatomyositis
3.patients with polymyositis/dermatomyositis who need muscle biopsy for evaluating disease activity
Key exclusion criteria
patients whom investigators judge ineligible
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | Natsuka |
| Middle name | |
| Last name | Umezawa |
Organization
Tokyo Medical and Dental University (TMDU)
Division name
Department of Rheumatology
Zip code
113-8519
Address
Yushima 1-5-45, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-6111
umezawa.rheu@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Natsuka |
| Middle name | |
| Last name | Umezawa |
Organization
Tokyo Medical and Dental University (TMDU)
Division name
Department of Rheumatology
Zip code
113-8519
Address
Yushima 1-5-45, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-6111
Homepage URL
umezawa.rheu@tmd.ac.jp
Sponsor or person
Institute
Department of Rheumatology, Tokyo Medical and Dental University (TMDU)
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Faculty of Medicine, Tokyo Medical and Dental University
Address
Yushima 1-5-45, Bunkyo-ku, Tokyo, Japan
Tel
03-3813-6111
syomu1.adm@tmd.ac.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
| 2016 | Year | 02 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 22 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 18 | Day |
Last modified on
| 2023 | Year | 03 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023615
