UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045711 |
|---|---|
| Receipt number | R000052178 |
| Scientific Title | Evaluation of subclinical inflammation at the enthesis of Achilles tendon in psoriasis and psoriatic arthritis with bicomponent T2* analysis. |
| Date of disclosure of the study information | 2021/11/01 |
| Last modified on | 2024/10/17 15:15:36 |
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Basic information
Public title
Evaluation of Achilles tendon enthesis in psoriasis and psoriatic arthritis with MRI.
Acronym
Evaluation of Achilles tendon enthesis with MRI
Scientific Title
Evaluation of subclinical inflammation at the enthesis of Achilles tendon in psoriasis and psoriatic arthritis with bicomponent T2* analysis.
Scientific Title:Acronym
Bicomponent T2* analysis of Achilles tendon enthesis in psoriasis and psoriatic arthritis
Region
| Japan |
Condition
Condition
psoriasis, psoriatic arthritis
Classification by specialty
| Clinical immunology | Dermatology | Radiology |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Quantification of subclinical inflammation at the enthesis of Achilles tendon in psoriasis and psoriatic arthritis patients
Basic objectives2
Others
Basic objectives -Others
Assessment of inter-reader reliability about the quantification methods
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Compare the obtained short T2* value at the Achilles tendon enthesis among healthy volunteers, psoriasis, and psoriatic arthritis group
Key secondary outcomes
Inter-reader reliability of the calculated values
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
One MRI scan with same protocol
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Obtained informed consent
Healthy volunteers, psoriasis without arthritis, and psoriatic arthritis
Key exclusion criteria
Contraindication of MRI
Presence of metal in the scanned ankle
History of injury or surgery for the Achilles tendon
Healthy volunteers with symptom in the Achilles tendon
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Fukuda |
Organization
The Jikei University School of Medicine
Division name
Department of Radiology
Zip code
105-8471
Address
3-19-18, Nishi-shimbashi, Minato-ku, Tokyo
TEL
0334331111
takeshifukuda@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Fukuda |
Organization
The Jikei University School of Medicine
Division name
Department of Radiology
Zip code
105-8471
Address
3-19-18, Nishi-shimbashi, Minato-ku, Tokyo
TEL
0334331111
Homepage URL
takeshifukuda@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research (KAKENHI)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Jikei University School of Medicine
Address
3-25-8, Nishi-shimbashi, Minato-ku, Tokyo
Tel
03-3433-1111
rinri@jikei.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 | 11 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 09 | Month | 06 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 06 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Keep recruiting the participants
Management information
Registered date
| 2021 | Year | 10 | Month | 10 | Day |
Last modified on
| 2024 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052178
