UMIN-CTR Clinical Trial

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