UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018076 |
|---|---|
| Receipt number | R000020923 |
| Scientific Title | Clinical trial for novel minimally invasive synovial biopsy in rheumatic diseases |
| Date of disclosure of the study information | 2015/06/24 |
| Last modified on | 2015/06/24 23:49:12 |
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Basic information
Public title
Clinical trial for novel minimally invasive synovial biopsy in rheumatic diseases
Acronym
Clinical trial for novel minimally invasive synovial biopsy in rheumatic diseases
Scientific Title
Clinical trial for novel minimally invasive synovial biopsy in rheumatic diseases
Scientific Title:Acronym
Clinical trial for novel minimally invasive synovial biopsy in rheumatic diseases
Region
| Japan |
Condition
Condition
Rheumatic diseases
Classification by specialty
| Clinical immunology | Orthopedics |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To validate the safety, tolerability and efficacy of Ultrasonography guided synovial needle biopsy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Examination for safety
Early complication (30 minute after biopsy): Examine presence/absence of complication such as bleeding, neural symptom.
Late complication(5~7 days after biopsy): Examine infection and complication of biopsy needle inserting portion .
2. Examination for tolerability:
Evaluate pain, swelling, stiffness in 3 points; before biopsy, 30 minute after biopsy, 5-7 days after biopsy using by visual analog scale.
3. Examination for efficacy and reliability of tissue samples:
Count and measuring the size of sample and perform general histological and biological examination. Surplus samples were cultured and analyzed gene and protein expression in our laboratory.
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
Diagnosis
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Ultrasonography guided synovial needle biopsy
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Arthritic patients who have at least 1 swollen joint and require pathological examination for diagnosis and give written informed consent before study.
Key exclusion criteria
Patients who dismissed as inadequate for medical reason by attending doctor.
Target sample size
7
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsutomu Takeuchi |
Organization
Keio University School of Medicine
Division name
Division of Rheumatology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
tsutake@z5.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsuya Suzuki |
Organization
Keio University School of Medicine
Division name
Division of Rheumatology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
Homepage URL
katsuyas@z5.keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Health, Labour and Welfare Ministry
Organization
Division
Category of Funding Organization
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
慶應義塾大学病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 24 | 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
| 2014 | Year | 04 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 28 | 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 | 24 | Day |
Last modified on
| 2015 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020923
| 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 |
