UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045182 |
|---|---|
| Receipt number | R000051167 |
| Scientific Title | The analysis of immune cells in RA patients |
| Date of disclosure of the study information | 2021/08/18 |
| Last modified on | 2024/02/19 09:05:44 |
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Basic information
Public title
The analysis of immune cells in RA patients
Acronym
The analysis of immune cells in RA patients
Scientific Title
The analysis of immune cells in RA patients
Scientific Title:Acronym
The analysis of immune cells in RA patients
Region
| Japan |
Condition
Condition
Rheumatoid arthritis, Osteoarthritis, Healthy control
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to find pathogenic immune cell types in rheumatoid arthritis to develop novel therapeutic strategies.
Basic objectives2
Others
Basic objectives -Others
we are going to perform the gene expression analysis of immune cells using next-generation sequencer.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To achieve to analyze the comprehensive gene expression of immune cells which infiltrate into the inflamed joints in rheumatoid arthritis patients.
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
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Blood sampling
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
the patients who regularly receive medical care and who are going to receive joint surgery.
the patients who agree with participating the study.
For healthy subjects, we recruit the individuals who have no remarkable disorders.
All should be more than 20 in their age.
Key exclusion criteria
the individuals whom doctors decide not to recommend to participate in this study.
the individuals who are less than 20.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Nakajima |
| Middle name | |
| Last name | Hiroshi |
Organization
Chiba University Hospital
Division name
Allergy and Clinical Immunology
Zip code
2608670
Address
1-8-1 Inohana, Chiba City, Ciba, Japan
TEL
043-222-7171
nakajimh@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Tanaka |
| Middle name | |
| Last name | Shigeru |
Organization
Chiba University Hospital
Division name
Allergy and Clinical Immunology
Zip code
2608670
Address
1-8-1 Inohana, Chiba City, Chiba, Japan
TEL
043-222-7171
Homepage URL
stanaka@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Ministray of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Chiba University
IRB Contact (For public release)
Organization
Chiba University Hospital, Ethics Committee
Address
1-8-1 Inohana, Chiba City, Chiba, Japan
Tel
043-222-7171
hsp-seimei@chiba-u.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 | 08 | Month | 18 | 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 | 08 | Month | 16 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 13 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 18 | 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
the participants are recruited only in Chiba University hospital.
Management information
Registered date
| 2021 | Year | 08 | Month | 18 | Day |
Last modified on
| 2024 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051167
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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