UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027366 |
|---|---|
| Receipt number | R000031323 |
| Scientific Title | Basic study of sonographic diagnosis of Sjogren's syndrome for establishing the international diagnostic standard: Comparison of diagnostic ability with sialography and salivary gland scintigraphy, and analyzing factors related to diagnostic ability |
| Date of disclosure of the study information | 2017/06/01 |
| Last modified on | 2019/03/03 19:21:26 |
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Basic information
Public title
Basic study of sonographic diagnosis of Sjogren's syndrome for establishing the international diagnostic standard:
Comparison of diagnostic ability with sialography and salivary gland scintigraphy, and analyzing factors related to diagnostic ability
Acronym
Basic study of sonographic diagnosis of Sjogren's syndrome for establishing the international diagnostic standard
Scientific Title
Basic study of sonographic diagnosis of Sjogren's syndrome for establishing the international diagnostic standard:
Comparison of diagnostic ability with sialography and salivary gland scintigraphy, and analyzing factors related to diagnostic ability
Scientific Title:Acronym
Basic study of sonographic diagnosis of Sjogren's syndrome for establishing the international diagnostic standard
Region
| Japan |
Condition
Condition
Sjogren's syndrome
Classification by specialty
| Clinical immunology | Oto-rhino-laryngology | Radiology |
| Oral surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
-Evaluation of usefulness of sonography as an alternative diagnostic method of Sjogren's syndrome by comparison of diagnostic ability with sialography and salivary gland scintigraphy
-Extraction of factors contributing to improve diagnostic ability by analyzing various factors related to sonographic examination
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sonographic diagnostic ability for confirmed diagnosis
Diagnostic method: From the heterogeneity of internal echoes and atrophy of the glands, the confidence score as Sjogren's syndrome (SS) is evaluated in 5 grades (5: certainly SS, 1: definitely not SS).
Key secondary outcomes
Correlation of sonographic diagnostic ability and various factors such as imaging conditions at the time of examination, operator's experience, examination frequency and diagnostic ability
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Sonographic examination
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 with suspected Sjogren's syndrome or IgG4-related dacrioadenitis and sialadenitis
Key exclusion criteria
1. Patients with disorders in the salivary glands other than Sjogren's syndrome or IgG 4-related dacrioadenitis and sialadenitis
2. When the image obtained is difficult to be diagnosed due to reasons such as motion artifacts.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mayumi Shimizu |
Organization
Kyushu University Hospital
Division name
Department of Oral and Maxillofacial Radiology
Zip code
Address
Maidashi 3-1-1, Higashi-ku, Fukuoka 812-8582
TEL
092-642-6407
shimizu@rad.dent.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mayumi Shimizu |
Organization
Kyushu University Hospital
Division name
Department of Oral and Maxillofacial Radiology
Zip code
Address
Maidashi 3-1-1, Higashi-ku, Fukuoka 812-8582
TEL
092-642-6407
Homepage URL
shimizu@rad.dent.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Ministry 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)
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
| 2017 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2017 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 02 | Month | 15 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 17 | Day |
Last modified on
| 2019 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031323
