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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000015058
Receipt No. R000017517
Scientific Title The role of minor salivary gland biospy in the diagnosis of Sjogren's syndorome; retrospective study of 192 Japanese patients
Date of disclosure of the study information 2014/09/10
Last modified on 2014/09/04

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Basic information
Public title The role of minor salivary gland biospy in the diagnosis of Sjogren's syndorome; retrospective study of 192 Japanese patients
Acronym THe role of MSGB in the diagnosis of SS
Scientific Title The role of minor salivary gland biospy in the diagnosis of Sjogren's syndorome; retrospective study of 192 Japanese patients
Scientific Title:Acronym THe role of MSGB in the diagnosis of SS
Region
Japan

Condition
Condition Sjogren's syndrome
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To access minor salivary gland biopsy,and the diagnosis of Sjogren's syndrome using the American college of Rheumatology classification criteria for Sjogren's syndrome in 2012.
Basic objectives2 Others
Basic objectives -Others To evaluate FS > 1 in MSGB
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Focus Score
Key secondary outcomes Anti-SSA,Anti-SSB,Ocular Sign, Salivary scintigraphy

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
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria sicca symptoms
serological feature
rule out lymphoma and Mickuliz disease
Key exclusion criteria History of head and neck radiation treatment
IgG4-related disease
Hepatitis C infection
Sarcoidosis
Amyloidosis
Graft versus. host disease
Acquired immunodeficiency syndrome
Target sample size 192

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Natsumi Ikumi
Organization Nihon University school of medicine
Division name Hematology and Rheumatology
Zip code
Address 30-1 Ohyaguchi-kamicho, Itabashi-ku, Tokyo 173-8610 Japan
TEL 03-3972-8111
Email n_ikumi@live.jp

Public contact
Name of contact person
1st name
Middle name
Last name Moemi Ii
Organization Nihon University school of medicine
Division name Hematology and Rheumatology
Zip code
Address 30-1 Ohyaguchi-kamicho, Itabashi-ku, Tokyo 173-8610 Japan
TEL +81-(0)3-3972-8111
Homepage URL
Email ii.moemi@nihon-u.ac.jp

Sponsor
Institute Nihon University school of medicine
Institute
Department

Funding Source
Organization Self
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
Email

Secondary IDs
Secondary IDs YES
Study ID_1 RK-140110-1
Org. issuing International ID_1 Nihon University school of medicine, Itabashi Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 日本大学医学部附属板橋病院(東京都)

Other administrative information
Date of disclosure of the study information
2014 Year 09 Month 10 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 MSBG was performed 192 patients.
Cases of lymphoma, IgG4-related disease and graft vs. host disease (7 patients) were excluded.
There were 82 primary SS, 38 secondary SS, 22 non-ss with CTDs and 43 non-SS without CTDs to diagnose using ACR criteria.
Twenty four FS > 1 patients were noted in 29 RA, but diangosis of SS were done to only 14 patietns.
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 Main results already published
Date of protocol fixation
2009 Year 08 Month 31 Day
Date of IRB
Anticipated trial start date
2009 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Focus Score > 1 are useful for diagnosing SS. A significant number of patients with FS > 1 was found in both the SS and DM groups. However, patients with noncharacteristic SS may also have RA.

Management information
Registered date
2014 Year 09 Month 04 Day
Last modified on
2014 Year 09 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017517

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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