UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051872 |
|---|---|
| Receipt number | R000059096 |
| Scientific Title | Measurement of Nardilysin concentration in synovial fluid |
| Date of disclosure of the study information | 2023/08/09 |
| Last modified on | 2023/08/09 12:54:59 |
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Basic information
Public title
Measurement of Nardilysin concentration in synovial fluid
Acronym
Measurement of Nardilysin concentration in synovial fluid
Scientific Title
Measurement of Nardilysin concentration in synovial fluid
Scientific Title:Acronym
Measurement of Nardilysin concentration in synovial fluid
Region
| Japan |
Condition
Condition
Rheumatoid arthritis, knee osteoarthritis, meniscus injury, ligament injury
Classification by specialty
| Clinical immunology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the usefulness as a diagnostic biomarker for knee joint diseases by measuring synovial fluid and serum Nardilysin concentrations in patients with osteoarthritis, rheumatoid arthritis, and patients undergoing knee joint treatment for other reasons.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Between-group comparison of Nardilysin levels in synovial fluid and serum
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
1. Patients undergoing total knee replacement surgery or knee arthroscopic surgery at Shiga University of Medical Science Hospital Orthopedic Surgery during the study period, or patients requiring outpatient knee joint puncture
2. Gender does not matter
3. Age of 18 years old or older at the time of obtaining consent
4. Consent to participate in research can be obtained from the person in writing
Key exclusion criteria
1. Those who cannot consent to participate in this study
2. Subjects with severe anemia (hemoglobin 8g/dL or less)
3. Patients who are judged by the principal investigator or co-investigators to be inappropriate as subjects of this study
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Yasutaka |
| Middle name | |
| Last name | Amano |
Organization
Shiga University of Medical Science
Division name
Department of Orthopaedic Surgery
Zip code
520-2192
Address
Seta Tsukinowacho, Otsu City, Shiga Prefecture
TEL
077-548-2562
amano021@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Yasutaka |
| Middle name | |
| Last name | Amano |
Organization
Shiga University of Medical Science
Division name
Department of Orthopaedic Surgery
Zip code
520-2192
Address
Seta Tsukinowacho, Otsu City, Shiga Prefecture
TEL
077-548-2562
Homepage URL
amano021@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Sanyo Chemical Industries, Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiga University of Medical Science Research Ethics Committee
Address
Seta Tsukinowacho, Otsu City, Shiga Prefecture
Tel
077-548-3576
hqrec@belle.shiga-med.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
| 2023 | Year | 08 | Month | 09 | 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
| 2023 | Year | 06 | Month | 27 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 14 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Not in particular
Management information
Registered date
| 2023 | Year | 08 | Month | 09 | Day |
Last modified on
| 2023 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059096
| Research Plan | |
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| 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 |
