UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043704
Receipt number 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 21:27:42

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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 or person

Institute

Ministry of Health, Labor and Welfare (MHLW)

Institute

Department

Personal name



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

Value
https://center6.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