UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022998 |
|---|---|
| Receipt number | R000026508 |
| Scientific Title | Assesment of orthopedic infection disease using Next generation sequencing |
| Date of disclosure of the study information | 2016/08/01 |
| Last modified on | 2023/07/08 10:26:51 |
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Basic information
Public title
Assesment of orthopedic infection disease using Next generation sequencing
Acronym
Assesment of orthopedic infection disease using Next generation sequencing
Scientific Title
Assesment of orthopedic infection disease using Next generation sequencing
Scientific Title:Acronym
Assesment of orthopedic infection disease using Next generation sequencing
Region
| Japan |
Condition
Condition
orthopedic infection disease
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Identification of the origin organism in orthopedic infectious disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison between Next-generation sequencing and laboratory culture result
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Target diseases are cellulitis, purulent arthritis,osteomyelitis,vertebral osteomyelitis and surgical site infection.
2)disputable infection from clinical findings and infectious findings,fever up,redness and swelling.
Key exclusion criteria
1)The patient who has impossibility to undergo biopsy with technical term
2)The patient has hemorrhagic tendency regardless of endogenous or external factor
3)In addition,the patient who has determined impropriety from researcher
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinya Ogawa |
Organization
Tottori university faculty of medicine
Division name
Orthopedic surgery
Zip code
Address
36-1 Nishi-cho,Yonago,Tottori,JAPAN
TEL
0859-38-6587
geneamp2000@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinya Ogawa |
Organization
Tottori university faculty of medicine
Division name
Orthopedic surgery
Zip code
Address
36-1 Nishi-cho,Yonago,Tottori,JAPAN
TEL
0859-38-6587
Homepage URL
geneamp2000@gmail.com
Sponsor or person
Institute
Tottori university faculty of medicine
Institute
Department
Personal name
Funding Source
Organization
Seif 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
Address
Tel
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
| 2016 | Year | 08 | 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
Completed
Date of protocol fixation
| 2016 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 13 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2016 | Year | 07 | Month | 03 | Day |
Last modified on
| 2023 | 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=R000026508
