UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044801 |
|---|---|
| Receipt number | R000051158 |
| Scientific Title | Research to elucidate the pathogenesis of bone and soft tissue injuries and to develop new treatment methods |
| Date of disclosure of the study information | 2021/07/15 |
| Last modified on | 2022/07/08 19:53:15 |
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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
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
sera@keio.jp
Sponsor or person
Institute
Keio university
Institute
Department
Personal name
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
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.).
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Management information
Registered date
| 2021 | Year | 07 | Month | 08 | Day |
Last modified on
| 2022 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051158
