UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047794 |
|---|---|
| Receipt number | R000054485 |
| Scientific Title | Japan-systemic sclerosis observational study and registry |
| Date of disclosure of the study information | 2022/05/18 |
| Last modified on | 2024/05/29 09:13:15 |
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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
kuwanam@nms.ac.jp
Public contact
Name of contact person
| 1st name | Aki |
| Middle name | |
| Last name | Mandokoro |
Organization
SRD Co., Ltd.
Division name
Clinical Research Department
Zip code
104-0032
Address
3-4-8 Hatchobori, Chuo-ku, Tokyo 104-0032, Japan
TEL
03-5543-0302
Homepage URL
j-star@cro-srd.co.jp
Sponsor or person
Institute
NPO Japan PH Registry
Institute
Department
Personal name
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
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
844
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
No longer 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
| 2024 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054485
