UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015058
Receipt number 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 16:42:50

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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 or person

Institute

Nihon University school of medicine

Institute

Department

Personal name



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

Value
https://center6.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