UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023410 |
|---|---|
| Receipt number | R000026970 |
| Scientific Title | Epidermal fatty acid binding protein as a diagnostic marker in Sjogren Syndrome |
| Date of disclosure of the study information | 2016/07/30 |
| Last modified on | 2021/03/16 11:39:19 |
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Basic information
Public title
Epidermal fatty acid binding protein as a diagnostic marker in Sjogren Syndrome
Acronym
E-FABP and SS
Scientific Title
Epidermal fatty acid binding protein as a diagnostic marker in Sjogren Syndrome
Scientific Title:Acronym
E-FABP and SS
Region
| Japan |
Condition
Condition
Sjogren Syndrome
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the diagnostic efficacy of E-FABP in SS
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
E-FABP
Key secondary outcomes
Inflammatory cytokines
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Observation period:1 year
Interventions/Control_2
Visit number: Once
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Sjogren syndrome
Key exclusion criteria
Systemic disease other than SS
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Dogru |
| Middle name | |
| Last name | Murat |
Organization
Tokyo Dental College
Division name
Ophthalmology
Zip code
2728513
Address
Chiba Ichikawa Sugano 5-11-13
TEL
047-322-0151
muratodooru2005@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Dogru |
| Middle name | |
| Last name | Murat |
Organization
Tokyo Dental College
Division name
Ophthalmology
Zip code
2728513
Address
Chiba Ichikawa Sugano 5-11-13
TEL
047-322-0151
Homepage URL
muratodooru2005@yahoo.co.jp
Sponsor or person
Institute
Tokyo Dental College
Ophthalmology
Institute
Department
Personal name
Funding Source
Organization
Tokyo Dental College
Ophthalmology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Dental College
Address
Chiba Ichikawa Sugano 5-11-13
Tel
0463220151
mishii@tdc.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
I 15-89
Org. issuing International ID_1
Tokyo Dental College
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 | 07 | Month | 30 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
23
Results
The E-FABP concentration in tears tended to be significantly lower in patients with SS than healthy control subjects. The E-FABP concentration in tears significantly correlated with the results of dry eye parameters. The E-FABP concentration in tears appears to be related to ocular surface epithelial damage and tear stability and may be a promising novel biomarker in the diagnosis of SS.
Results date posted
| 2021 | Year | 03 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This was an observational case series study of newly diagnosed patients with untreated dry eye or dry mouth who were examined at Tokyo Dental College Ichikawa General Hospital and healthy control subjects.
Participant flow
The number used for outcome analysis, and the numbers used for statistical analysis were the same as those at the start of the study.
Adverse events
None
Outcome measures
E-FABP concentration in tears, salive, and serum, Dry eye symptom questionnaire, Tear function examination
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 02 | Month | 10 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 10 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 30 | Day |
Last modified on
| 2021 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026970
| Research Plan | |
|---|---|
| Registered date | File name |
| 2021/03/09 | 研究計画書.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2021/03/16 | 研究症例データ.docx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2021/03/16 | ＦＡＢＰ 研究症例データ.xlsx |
