UMIN-CTR Clinical Trial

Basic information
Public title	Research to elucidate the pathogenesis of bone and soft tissue injuries and to develop new treatment methods
Acronym	Research to elucidate the pathogenesis of bone and soft tissue injuries and to develop new treatment methods
Scientific Title	Research to elucidate the pathogenesis of bone and soft tissue injuries and to develop new treatment methods
Scientific Title:Acronym	Research to elucidate the pathogenesis of bone and soft tissue injuries and to develop new treatment methods
Region	Japan

Condition
Condition	Bone and soft tissue injuries
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	We will investigate clinical information, cell fractionation in blood and tissue, gene expression, and protein expression in bone and soft tissue injuries to further elucidate pathogenesis and search for therapeutic target molecules.
Basic objectives2	Others
Basic objectives -Others	We will investigate clinical information, cell fractionation in blood and tissue, gene expression, and protein expression in bone and soft tissue injuries to further elucidate pathogenesis and search for therapeutic target molecules.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	gene expression
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	1 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients with bone and soft tissue injuries such as fracture, separation, osteochondritis dissecans, anterior cruciate ligament injury, patellar tendinitis, etc.
Key exclusion criteria	Those who have not consented to this study. Those who are judged as inappropriate by the attending physician.
Target sample size	10000

Research contact person
Name of lead principal investigator	1st name Kazuki Middle name Last name Sato
Organization	Keio University
Division name	Institute for Integrated Sports Medicine, School of Medicine
Zip code	1608582
Address	35, Shinanomachi, Shinjuku-ku, Tokyo
TEL	0333531211
Email	kazuki@a5.keio.jp

Public contact
Name of contact person	1st name Yasushi Middle name Last name Sera
Organization	Keio University
Division name	Institute for Integrated Sports Medicine, School of Medicine
Zip code	1608582
Address	35, Shinanomachi, Shinjuku-ku, Tokyo
TEL	0333531211
Homepage URL
Email	sera@keio.jp

Sponsor
Institute	Keio university
Institute
Department

Funding Source
Organization	self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Keio University
Address	35, Shinanomachi, Shinjuku-ku, Tokyo
Tel	0333531211
Email	med-rinri-jimu@adst.keio.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	2021 Year 07 Month 15 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	0
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	Terminated
Date of protocol fixation	2020 Year 07 Month 28 Day
Date of IRB	2020 Year 05 Month 29 Day
Anticipated trial start date	2021 Year 07 Month 01 Day
Last follow-up date	2030 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

We will take clinical records and analyze tissue examinations for the diagnosis of bone and soft tissue injuries (fractures, cartilage damage, tentacle damage, tendonitis, flesh separation, etc.). The clinical information obtained from the consultation includes the patient's background (age, sex, length, weight, history of alcohol consumption, history of smoking, past history, history of exercise, history of internal medication, etc.), images (radiographs, CT, MRI, ultrasound, etc.), investigations (blood tests, urine tests, bone density tests, pathological histograms, etc.). Translated with www.DeepL.com/Translator (free version)

Management information
Registered date	2021 Year 07 Month 08 Day
Last modified on	2022 Year 07 Month 08 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051158