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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000024807
Receipt No. R000028548
Scientific Title Efficacy and long-term outcome of acquired chronic pure red cell aplasia in adults
Date of disclosure of the study information 2016/12/01
Last modified on 2016/11/11

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Basic information
Public title Efficacy and long-term outcome of acquired chronic pure red cell aplasia in adults
Acronym Zouketsushougaihan pure red cell aplasia cohort study (PRCA2016)
Scientific Title Efficacy and long-term outcome of acquired chronic pure red cell aplasia in adults
Scientific Title:Acronym Zouketsushougaihan pure red cell aplasia cohort study (PRCA2016)
Region
Japan

Condition
Condition Acquired chronic pure red cell aplasia
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In order to establish an optimal management of acquired pure red cell aplasia (PRCA) in adults, the efficacy of immunosuppressive therapy and long-term survival are investigated by employing a cohort longitudinal observational study.
Basic objectives2 Others
Basic objectives -Others Efficacy of immunosuppressive therapy and the role for iron-chelation therapy in transfusion-dependent patients are also investigated.
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Overall survival
Key secondary outcomes Response rate of immunosuppressive therapy, efficacy of iron-chelation therapy in transfusion-dependent patients

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
15 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria Acquired chronic pure red cell aplasia
Key exclusion criteria Acute pure red cell aplasia, congenital pure red cell aplasia
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Hirokawa
Organization Akita University Graduate School of Medicine
Division name Department of General Internal Medicine and Clinical Laboratory Medicine
Zip code
Address Hondo 1-1-1, Akita 010-8543, Japan
TEL 018-884-6209
Email mhirokawa@hos.akita-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Hirokawa
Organization Akita University Graduate School of Medicine
Division name Department of General Internal Medicine and Clinical Laboratory Medicine
Zip code
Address 1-1-1 Hondo, Akita 010-8543, Japan
TEL 018-884-6209
Homepage URL
Email mhirokawa@hos.akita-u.ac.jp

Sponsor
Institute Akita University
Institute
Department

Funding Source
Organization Idiopathic Disorders of Haematopoietic Organs Research Committee of the Ministry of Health, Labour and Welfare of Japan
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
Address
Tel
Email

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
2016 Year 12 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 Preinitiation
Date of protocol fixation
2015 Year 12 Month 06 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Not applicable

Management information
Registered date
2016 Year 11 Month 11 Day
Last modified on
2016 Year 11 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028548

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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