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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000020612
Receipt No. R000023615
Scientific Title Efficacy of conchotome muscle biopsy
Date of disclosure of the study information 2016/02/01
Last modified on 2020/08/06

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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
Email 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
Email umezawa.rheu@tmd.ac.jp

Sponsor
Institute Department of Rheumatology, Tokyo Medical and Dental University (TMDU)
Institute
Department

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
Email 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
Anticipated trial start date
2016 Year 02 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
2016 Year 01 Month 18 Day
Last modified on
2020 Year 08 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023615

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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