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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000012807
Receipt No. R000014954
Scientific Title Japanese study of Anti-ccp antibody SCreENing methoD in general health check up
Date of disclosure of the study information 2014/01/10
Last modified on 2018/01/12

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Basic information
Public title Japanese study of Anti-ccp antibody SCreENing methoD in general health check up
Acronym J-ASCEND
Scientific Title Japanese study of Anti-ccp antibody SCreENing methoD in general health check up
Scientific Title:Acronym J-ASCEND
Region
Japan

Condition
Condition Rheumaid Arthritis
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate diagnostic performance of anit-CCP antibody test as a
screening test at medical health checkup in general population.
Basic objectives2 Others
Basic objectives -Others To evaluate the impact of anti-CCP antibody screening on patients'
outcome and its economic effect.
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes The positivity rate of anti-CCP antibody in general population and
number of the patients who are diagnosed as rheumatoid arthritis by
this screening method.
Key secondary outcomes Patients' outcome and economic effect of anti-CCP antibody screening test.

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

Not applicable
Gender Male and Female
Key inclusion criteria We check anti-CCP antibody in people who visits our health check up institutions and agree to the test.
Key exclusion criteria Patients who already has been diagnosed as rheumatoid arthritis or who disagrees to this study are excluded.
Target sample size 25000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masato Okada
Organization St.Lukes International Hospital
Division name Division of Allergy and Rheumatology
Zip code
Address 9-1 Akashi-cho, Chuo-Ku, Tokyo
TEL 03-3541-5151
Email bestlupusdoctorever@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Masato Okada
Organization St.Lukes International Hospital
Division name Division of Allergy and Rheumatology
Zip code
Address 9-1 Akashi-cho, Chuo-Ku, Tokyo
TEL 03-3541-5151
Homepage URL
Email bestlupusdoctorever@gmail.com

Sponsor
Institute St.Lukes International Hospital
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
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
2014 Year 01 Month 10 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Enrolling by invitation
Date of protocol fixation
2013 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 11 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 After obtainig the consent, they were collected serum samples. Anti-CCP antibody and rheumatoid factor are examined. Antibody-positive persons are examined by Rheumatologists directly, and classified as follows; 1. Early RA group: the person with the diagnosis of rheumatoid arthritis, 2. Pre-RA groups: the person with joint symptoms, 3. Non-RA group: the person with no symptoms. Then they are followed up at regular intervals. For early RA group, its treatment is done by Rheumatologist in line with guidelines. When they develop rheumatoid arthritis, they will be treated as in the early RA group. After this study started, disease activity measure (CDAI, SDAI, DAS28, DAS28-CRP), ADL(HAQ-DI), X ray evaluation (modified Total Sharp Score), and medical cost will be checked annualy.

Management information
Registered date
2014 Year 01 Month 09 Day
Last modified on
2018 Year 01 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014954

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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