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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000047794
Receipt No. R000054485
Scientific Title Japan-systemic sclerosis observational study and registry
Date of disclosure of the study information 2022/05/18
Last modified on 2022/05/18

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Basic information
Public title Japan-systemic sclerosis observational study and registry
Acronym J-STAR
Scientific Title Japan-systemic sclerosis observational study and registry
Scientific Title:Acronym J-STAR
Region
Japan

Condition
Condition Systemic sclerosis
Classification by specialty
Clinical immunology Chest surgery Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In this registry, data shown below will be collected prospectively and retrospectively.
To assess prevalence rate of SSc organ involvement, mortality rate, and time to organ involvement in Japanese patients with systemic sclerosis (SSc).
To assess cumulative frequency of progressive fibrosing interstitial lung disease (ILD) in Japanese patients with SSc for 12 and 36 months of follow-up.
To identify clinical and physiological findings, imaging features, and biomarkers that predict SSc major organ involvement, including progression of ILD.
Basic objectives2 Others
Basic objectives -Others Others
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Time to onset of SSc organ involvement defined by previous studies
A)ILD
B)PH
C)Renal crisis
D)Upper gastrointestinal involvement
E)Lower gastrointestinal involvement
F)Myocardial involvement
G)Digital ulcer
Key secondary outcomes A)Time to onset of organ failure event
B)Time to death
C)Rate of patients who meet the criteria of low disease activity advocated by World Scleroderma Foundation: WSF (at 1, 2, 3 years)
D)Rate of patients with progressive pulmonary fibrosis (at 1, 3 years)
E)Predictive factor for progression of pulmonary fibrosis in patients with SSc-ILD

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 1)Patients who give written consent (provide opportunity to refuse, to the patients who had been registered in EUSTAR database and with difficulty in written consent)
2)20 years or older at the time of consent
3)Patients who are diagnosed as having SSc and meet the 2013 American college of Rheumatology (ACR)/ European League against Rheumatism (EULAR) classification criteria for SSc;
4)Patients with or without ILD. In case of SSc-ILD patients, ILD has been confirmed by high-resolution computed tomography (HRCT) at the time of baseline or follow-up.
5)Accepted whether registered in EUSTAR database or not. In patients who have been registered in EUSTAR database, the data recorded in EUSTAR database may be collected retrospectively.
Key exclusion criteria 1)Participation in clinical trials for NDA concurrently or scheduled during this registry, excluding studies other than clinical trials for NDA (e.g., specified clinical trial defined in Clinical Trials Act)
2)Unsuitable for enrolment into this study by the investigator's or sub-investigator's judgment
Target sample size 800

Research contact person
Name of lead principal investigator
1st name Masataka
Middle name
Last name Kuwana
Organization Nippon Medical School Hospital
Division name Department of Rheumatology
Zip code 113-8603
Address 1-1-5 Sendagi, Bunkyo-ku, Tokyo, Japan
TEL 03-3822-2131
Email kuwanam@nms.ac.jp

Public contact
Name of contact person
1st name Takako
Middle name
Last name Osato
Organization EPS Corporation
Division name Clinical Research Center, Real World Evidence Business Headquarters
Zip code 162-0814
Address Acropolis TOKYO, 6-29 Shin-ogawamachi, Shinjuku-ku, Tokyo, Japan
TEL 03-5804-5045
Homepage URL
Email prj-jstar@eps.co.jp

Sponsor
Institute NPO Japan PH Registry
Institute
Department

Funding Source
Organization Nippon Boehringer lngelheim Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Central Ethics Committee of Nippon Medical School
Address 1-1-5 Sendagi, Bunkyo-ku, Tokyo, Japan 113-8603
Tel 03-3822-2131
Email chuorinri.group@nms.ac.jp

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 日本医科大学付属病院(東京都)、公立陶生病院(愛知県)、産業医科大学病院(福岡県)、北海道大学病院(北海道)、東京女子医科大学病院(東京都)、藤田医科大学病院(愛知県)、札幌医科大学附属病院(北海道)、長崎大学病院(長崎県)、浜松医科大学医学部附属病院(静岡県)、久留米大学病院(福岡県)、大阪医科薬科大学病院(大阪府)、香川大学医学部附属病院(香川県)、学校法人北里研究所 北里大学病院(神奈川県)、慶應義塾大学病院(東京都)、東北大学病院(宮城県)
、地方独立行政法人 神奈川県立病院機構 神奈川県立循環器呼吸器病センター 
(神奈川県)、徳島大学病院(徳島県)、九州大学病院(福岡県)、独立行政法人 地域医療機能推進機構 中京病院(愛知県)、公立大学法人 横浜市立大学附属病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2022 Year 05 Month 18 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 Open public recruiting
Date of protocol fixation
2021 Year 10 Month 21 Day
Date of IRB
2021 Year 12 Month 20 Day
Anticipated trial start date
2022 Year 01 Month 05 Day
Last follow-up date
2028 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information NA

Management information
Registered date
2022 Year 05 Month 18 Day
Last modified on
2022 Year 05 Month 18 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054485

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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