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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029812
Receipt No. R000034058
Scientific Title Evidence creation through nationwide surveillance of the progeria syndrome Werner syndrome and establishment of a case registration system
Date of disclosure of the study information 2017/11/03
Last modified on 2020/11/05

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Basic information
Public title Evidence creation through nationwide surveillance of the progeria syndrome Werner syndrome and establishment of a case registration system
Acronym Werner syndrome registry
Scientific Title Evidence creation through nationwide surveillance of the progeria syndrome Werner syndrome and establishment of a case registration system
Scientific Title:Acronym Werner syndrome registry
Region
Japan

Condition
Condition Werner Syndrome
Classification by specialty
Medicine in general Endocrinology and Metabolism Geriatrics
Ophthalmology Dermatology Orthopedics
Plastic surgery
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 In order to solve the clinical questions regarding with the adult progeria, Werner Syndrome, and establish high quality evidence that contributes to the revision of clinical practice guidelines of Werner Syndrome, we have the nationwide survey and establish the Werner Syndrome registration system. By the survey and registration system, we can reveal the current disease profile, the natural history, and prognosis of Werner Syndrome in Japan. We also have a clinical trial for Werner Syndrome. Therefore, we will be able to contribute to the revision of the current clinical practice guideline of Werner Syndrome, which was published based on the result of previous Practical Research Project for Rare Intractable Diseases. We are trying to improve the patient prognosis and supported the patient social reintegration, by the popularization and quality improvement of medical treatment for Werner Syndrome.
Basic objectives2 Others
Basic objectives -Others (A) Establishment and management of Werner Syndrome registration system
(B) Data collection and analysis of Werner Syndrome
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes (This is a patient registry.)
We will clarify current disease profile, natural history and prognosis of WS in Japan through the results of this research and improve patient data accuracy and use effectively, and improve medical system for WS. We will be able to rescue patients who do not have appropriate medical treatment and support patient's prognosis improvement and reintegration by improving the quality of medical treatment.
Key secondary outcomes

Base
Study type Others,meta-analysis etc

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients whom diagnosed as Werner Syndrome or related diseases.
2. Patients who wrote informed consent.
Key exclusion criteria N/A
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Koutaro
Middle name
Last name Yokote
Organization Chiba University
Division name Graduate school of medicine
Zip code 260-8670
Address 1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, Japan
TEL 0432262092
Email kyokote@faculty.chiba-u.jp

Public contact
Name of contact person
1st name Masaya
Middle name
Last name Koshizaka
Organization Chiba University
Division name Graduate school of medicine
Zip code 260-8670
Address 1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, Japan
TEL 0432262092
Homepage URL http://www.m.chiba-u.jp/class/clin-cellbiol/werner/result/registry.html
Email overslope@chiba-u.jp

Sponsor
Institute Japan Agency for Medical Research and Development
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
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 Chiba University
Address 1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, Japan
Tel 0432227171
Email igaku-rinri@office.chiba-u.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

Other administrative information
Date of disclosure of the study information
2017 Year 11 Month 03 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
2016 Year 01 Month 01 Day
Date of IRB
2016 Year 07 Month 27 Day
Anticipated trial start date
2016 Year 04 Month 01 Day
Last follow-up date
2030 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information (A) Establishment and management of WS registration system
We prepared a data sheet for WS registration system, based on the previous survey and referring to domestic and international intractable disease registration systems. We have established WS registration system, used DATATRACK ONE (NTT DATA), supported by the Chiba University Clinical Research Center. We also have employed a data manager and developed a registry infrastructure.

(B) Data collection and analysis of WS
We have conducted a nationwide primary survey to find patients who were not diagnosed, by collaboration with the National Health Labor Science Research Policy Research Project. We also have gathered and updated the primary information of WS patients, based on the results of the previous nationwide survey conducted in 2009. We have prepared for mail survey / guidance requesting participation in the WS registration system. We will ask each medical institution to participate in the WS registration system in the next year. We are also seeking cooperation from patients and family associations for the WS registration. We are requesting to acquire informed consent and have first survey of case information and secondary survey, in which we collect the data of clinical symptoms / natural history (course from onset to treatment start), mutation pattern of the causative gene, and treatment contents. We are also collecting and registering blood samples, gene specimens and skin slices for cases that agree to do. We will collect patients data annually, in order to have cross-sectional analysis. We will utilize the data obtained including the longitudinal analysis by follow-up data as evidence for revision of WS clinical practice guidelines (conducted by the laboratory science research intractable disease policy research project).

Management information
Registered date
2017 Year 11 Month 03 Day
Last modified on
2020 Year 11 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034058

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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