UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033523 |
|---|---|
| Receipt number | R000038225 |
| Scientific Title | Screening for the optimum urinary biomarkers indicating cartilage wear in the knee. |
| Date of disclosure of the study information | 2018/09/01 |
| Last modified on | 2019/03/31 22:37:50 |
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Basic information
Public title
Screening for the optimum urinary biomarkers indicating cartilage wear in the knee.
Acronym
Urinary biomarker screening for the knee OA
Scientific Title
Screening for the optimum urinary biomarkers indicating cartilage wear in the knee.
Scientific Title:Acronym
Urinary biomarker screening for the knee OA
Region
| Japan |
Condition
Condition
Cartilage injury
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the optimum urinary biomarker which indicate the magnitude of cartilage were of the knee.
Basic objectives2
Others
Basic objectives -Others
To obtain metabolome data of healthy volunteer with no history of knee ailment or injury.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Metabolome analysis of healthy volunteer with no history of knee ailment or injury.
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
| Other |
Interventions/Control_1
Urine sample collection
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
To obtain lawfully valid consent, we include more than 20 years old healthy volunteers.
The incidence of osteoarthritis increases in proportional to one's age, so we include less than 60 years old healthy volunteers for the candidates.
Key exclusion criteria
Exclusion criteria includes, but not limited to, the below item.
1.Severe cognitive dysfunction to obtain written informed consent.
2.History of knee surgery, knee injury treated more than 3 months, lower extremity osteoarthritis or long bone fracture, systemic arthritic disease,
3.Patients of severe cardiovascular, hepatic, renal, diabetic, mental, and malignant diseases.
4.Pregnant women.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | N/A |
| Last name | Sekiya |
Organization
Tokyo Medical and Dental University
Division name
Center of Stem Cell and Regenerative Medicine
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku
TEL
0358034017
sekiya.arm@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Office administrator |
| Middle name | N/A |
| Last name | Office administrator |
Organization
Tokyo Medical and Dental University
Division name
Center of Stem Cell and Regenerative Medicine
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku
TEL
0358034017
Homepage URL
saisei01.arm@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Fujifilm Corporation
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
IRB for TMDU
Address
1-5-45 Yushima, Bunkyo-ku
Tel
0358036111
info.bec@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
| 2018 | Year | 09 | 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
| 2018 | Year | 07 | Month | 26 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 19 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 19 | Day |
Last follow-up date
| 2021 | 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
| 2018 | Year | 07 | Month | 26 | Day |
Last modified on
| 2019 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038225
