UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035088 |
|---|---|
| Receipt number | 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 12:36:49 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
kyoshi@sanken.osaka-u.ac.jp
Sponsor or person
Institute
Department of Biomolecular Science and Regulation, The Institute of Scientific and Industrial Research, Osaka University, Osaka, Japan
Institute
Department
Personal name
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
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
Value
https://center6.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 |
