UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037531 |
|---|---|
| Receipt number | R000042696 |
| Scientific Title | Surveys of patients with Sjogren's syndrome prior to diagnosis and at the present in Japan |
| Date of disclosure of the study information | 2019/10/01 |
| Last modified on | 2023/08/06 20:30:28 |
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Basic information
Public title
Surveys of patients with Sjogren's syndrome prior to diagnosis and at the present in Japan
Acronym
Surveys in Sjogren's syndrome in Japan
Scientific Title
Surveys of patients with Sjogren's syndrome prior to diagnosis and at the present in Japan
Scientific Title:Acronym
Surveys in Sjogren's syndrome in Japan
Region
| Japan |
Condition
Condition
Sjogren's syndrome
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify process until diagnosis of Sjogren's syndrome
Basic objectives2
Others
Basic objectives -Others
To clarify a novel symptom for early diagnosis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
period from when a patients noticed unusual symptoms to when Sjogren syndrome was diagnozed.
Key secondary outcomes
details of the symptoms, how a patient was diagnozed by and how many hospitals a patients had visted until the diagnosis
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
Paients with Sjogren's sydrome and Members in the Japanese Sjogren's association for patients (JSAP)
Key exclusion criteria
None
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Komori |
Organization
Kochi Medical School
Division name
Department of Otolaryngology
Zip code
783-8505
Address
Kohasu, Oko-cho, Nankoku-shi, Kochi
TEL
+81888802393
komori@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Komori |
Organization
Kochi Medical School
Division name
Department of Otolaryngology
Zip code
783-8505
Address
Kohasu, Oko-cho, Nankoku-shi, Kochi
TEL
+81888802393
Homepage URL
komori@kochi-u.ac.jp
Sponsor or person
Institute
Kochi University
Institute
Department
Personal name
Funding Source
Organization
Kochi University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kochi Medical School
Address
Kohasu, Oko-cho, Nankoku-shi, Kochi
Tel
+81888802180
is21@kochi-u.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
| 2019 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
None
Publication of results
Partially published
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
276
Results
The average time to diagnosis was 3.47 years. After adjustment, risk factors for delayed diagnosis were initial visit to an internal medicine department or ophthalmology department, younger age at initial visit to hospital or clinic, and having symptoms of only dry eye.
Results date posted
| 2023 | Year | 08 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 12 | Month | 15 | Day |
Baseline Characteristics
Members of the Japanese Sjogren Association for patients
Participant flow
Of the 510 patients questioned, 276 returned the questionnaire.
Adverse events
There have not been any adverse events.
Outcome measures
factors associated with delayed diagnosis.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2019 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
How long the patients spent and how many they saw doctors until the diagnosis, and unusual symptoms and present conditions concerning with Sjogren's disease are investigated using questionnaire.
Management information
Registered date
| 2019 | Year | 07 | Month | 29 | Day |
Last modified on
| 2023 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042696
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
