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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033523
Receipt No. 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

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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
Email 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
Email saisei01.arm@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038225

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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