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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035088
Receipt No. R000039999
Scientific Title Research on epidemiological clinical practice survey of Castleman disease
Date of disclosure of the study information 2018/12/12
Last modified on 2019/06/01

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Basic information
Public title Research on epidemiological clinical practice survey of Castleman disease
Acronym Research on epidemiological clinical practice survey of Castleman disease
Scientific Title Research on epidemiological clinical practice survey of Castleman disease
Scientific Title:Acronym Research on epidemiological clinical practice survey of Castleman disease
Region
Japan North America

Condition
Condition Castleman disease
Classification by specialty
Hematology and clinical oncology Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 It aims at grasping the actual condition of patient care and treatment, establishing classification and diagnosis of disease, disseminating effective treatment methods and establishing treatment guidelines
Basic objectives2 Others
Basic objectives -Others prepare medical treatment guidelines for Castleman disease
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Clinical data, multi-suspension array of serum / plasma, serum antibody array, microarray, immunocomplex LC-MS / MS, flow cytometry, biopsy tissue array
Key secondary outcomes

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria A case diagnosed as Castleman Disease. Hyaline vascular type, plasma cell type and intermediate type. Plasma cell type can be HHV 8 positive or negative.
Key exclusion criteria A case that the doctor judged inappropriate.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Mizuki
Middle name
Last name Masao
Organization Osaka University Hospital
Division name Chemotherapy and oncology center
Zip code 565-0871
Address 2-2 Yamadaoka Suita City, Osaka
TEL 06-6879-3871
Email mizuki@bldon.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name Yoshizaki
Middle name
Last name Kazuyuki
Organization Institute of Scientific and Industrial Research
Division name Department of Biomolecular Science and Regulation, The
Zip code 567-0047
Address 8-1 Mihogahigaoka, Ibaraki-shi, Osaka
TEL 06-6877-5737
Homepage URL
Email kyoshi@sanken.osaka-u.ac.jp

Sponsor
Institute Department of Biomolecular Science and Regulation, The Institute of Scientific and Industrial Research, Osaka University, Osaka, Japan
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 Osaka University Medical School Hospital Observation Research Ethics Review Committee
Address 2 -2 Yamadaoka, Suita-shi, Osaka
Tel 06-6210-8296
Email mizuki@bldon.med.osaka-u.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

Other administrative information
Date of disclosure of the study information
2018 Year 12 Month 12 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
2018 Year 10 Month 08 Day
Date of IRB
2019 Year 01 Month 22 Day
Anticipated trial start date
2018 Year 12 Month 12 Day
Last follow-up date
2024 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Clinical data
Serum / plasma multi-suspension array, serum antibody array, microarray, immunocomplex LC-MS / MS
Flow cytometry
Biopsy tissue array

Management information
Registered date
2018 Year 11 Month 30 Day
Last modified on
2019 Year 06 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039999

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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