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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027366
Receipt No. 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

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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
Email 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
Email shimizu@rad.dent.kyushu-u.ac.jp

Sponsor
Institute Kyushu University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031323

Research Plan
Registered date File name
2018/05/20 keikakusho最終.pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name


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