UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000043704
Receipt No. R000049901
Scientific Title Prospective registration program / central review of morphologic diagnosis / follow-up study / genomic research for aplastic anemia and myelodysplastic syndromes.
Date of disclosure of the study information 2021/04/01
Last modified on 2021/04/05

* 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 Prospective registration program / central review of morphologic diagnosis / follow-up study / genomic research for aplastic anemia and myelodysplastic syndromes.
Acronym Registration for AA and MDS.
Scientific Title Prospective registration program / central review of morphologic diagnosis / follow-up study / genomic research for aplastic anemia and myelodysplastic syndromes.
Scientific Title:Acronym G1268/RADDAR-J
Region
Japan

Condition
Condition Aplastic anemia (AA)
Myelodysplastic syndromes (MDS)
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 The aim of the study is to obtain general agreement on diagnosis of AA and MDS, and to clarify clinical outcomes of current treatment practice in Japan. Moreover, we utilize the collected data for development of novel therapeutic strategies.
Basic objectives2 Others
Basic objectives -Others To obtain diagnostic criteria.
To obtain treatment outcomes.
To obtain base line data for development of novel therapeutic strategies.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The assessment including cellularity of bone marrow, presence and frequency of dysplasia, evaluation of other notable morphological findings, and morphologic diagnosis by central review.
The evaluation of clinical outcomes under current treatment practice in Japan and of therapeutic efficacy by prospective registration program.
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 Newly diagnosed aplastic anemia and MDS, or cases with difficulties to distinguish between AA from MDS.
Key exclusion criteria The case without documented consensus is excluded.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Akifumi
Middle name
Last name Takaori
Organization Graduate School of Medicine, Kyoto University
Division name Faculty of Medicine, Department of Hematology and Oncology
Zip code 606-8507
Address 54 Shogoin-kawaramachi, Sakyo-ku, Kyoto
TEL 075-751-3150
Email atakaori@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name Junya
Middle name
Last name Kanda
Organization Graduate School of Medicine, Kyoto University
Division name Faculty of Medicine, Department of Hematology and Oncology
Zip code 606-8507
Address 54 Shogoin-kawaramachi, Sakyo-ku, Kyoto
TEL 075-751-3152
Homepage URL http://zoketsushogaihan.umin.jp/index.html
Email aamds@kuhp.kyoto-u.ac.jp

Sponsor
Institute Ministry of Health, Labor and Welfare (MHLW)
Institute
Department

Funding Source
Organization Ministry of Health, Labor and Welfare (MHLW)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Executive manager for central review: Department of Hemato-Oncology, Saitama Medical University International Medical Center

Practitioners for central review :
Molecular Medicine Unit, Atomic Bomb Disease Institute, Nagasaki University
Department of Hemato-Oncology, Saitama Medical University International Medical Center
Department of Hematology, Kitasato University
Department of Hematology, National Hospital Organization Kyoto Medical Center
Department of Laboratory Medicine, Kawasaki Medical University
School of Medical Technology, Faculty of Health and Medical Care, Saitama Medical University
Clinical Examination Center, Dokkyo Medical University Hospital
Name of secondary funder(s) Japan Agency for Medical Research and Development (AMED)

IRB Contact (For public release)
Organization Kyoto University Graduate School and Faculty of Medicine, Kyoto University Hospital Ethics Committee
Address Yoshida-Konoe-cho, Sakyo-ku, Kyoto
Tel 075-753-4680
Email ethcom@kuhp.kyoto-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 京都大学大学院(京都府)/Kyoto University Graduate School of Medicine (Kyoto)

Other administrative information
Date of disclosure of the study information
2021 Year 04 Month 01 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
2020 Year 05 Month 25 Day
Date of IRB
2020 Year 10 Month 16 Day
Anticipated trial start date
2021 Year 04 Month 01 Day
Last follow-up date
2041 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information morphologic diagnosis, efficacy of treatment, prognostic factor, genomic research

Management information
Registered date
2021 Year 03 Month 22 Day
Last modified on
2021 Year 04 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049901

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.