UMIN-CTR Clinical Trial

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
Last 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
1st 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