UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014983 |
|---|---|
| Receipt number | R000017413 |
| Scientific Title | Comprehensive analysis of biological factors in patients with uveitis |
| Date of disclosure of the study information | 2014/08/29 |
| Last modified on | 2024/03/05 09:58:14 |
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Basic information
Public title
Comprehensive analysis of biological factors in patients with uveitis
Acronym
Researches for uveitis
Scientific Title
Comprehensive analysis of biological factors in patients with uveitis
Scientific Title:Acronym
Researches for uveitis
Region
| Japan |
Condition
Condition
Uveitis
Intraocular lymphoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To analyze the association of biomarkers (inflammatory mediators) and the activities of the disease severity in patients with uveitis.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Inflammatory mediators(virus genes, cytokines and chemokines and their receptors in serum and intraocular fluids)
Visual function (Visual acuity, IOP, visual field, and fundus photo and COT, etc.)
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
Patients who are diagnosed according to clinical criteria and have had a medical examination in Kyushu University Hospital
Key exclusion criteria
(1)Patients with anemia
(2)Patients with poor systemic conditions
(3)Unsuitable patients judged by researchers
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuro Ishibashi |
Organization
Graduate School of Medical Sciences, Kyushu Unicersity
Division name
Department of Ophthalmology
Zip code
Address
3-1-1 Maidashi, Higahi-ku, Fukuoka
TEL
092-642-5648
atakeda@med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsunobu Takeda |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Ophthalmology
Zip code
Address
3-1-1 Maidashi, Higahi-ku, Fukuoka
TEL
092-642-5648
Homepage URL
atakeda@med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Graduate School of Medical Sciences, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Department of Ophthalmology, Graduate School of Medical Sciences, Kyushu University
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
| 2014 | Year | 08 | Month | 29 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 02 | Month | 18 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 09 | Day |
Anticipated trial start date
| 2013 | Year | 02 | Month | 18 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2028 | Year | 12 | Month | 31 | Day |
Other
Other related information
Under inverstigation
Management information
Registered date
| 2014 | Year | 08 | Month | 28 | Day |
Last modified on
| 2024 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017413
