UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024807 |
|---|---|
| Receipt number | 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 | 2024/01/05 14:15:45 |
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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 | Fumihiro |
| Middle name | |
| Last name | Ishida |
Organization
Shinshu University School of Medicine
Division name
Depertment of Biomedical Laboratory Sciences
Zip code
390-0802
Address
3-1-1, Asahi, Matsumoto-shi, Nagano, 390-0802, Japan
TEL
0263-37-2554
fumishi@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Kaoko |
| Middle name | |
| Last name | Sakai |
Organization
Shinshu University School of Medicine
Division name
Department of Hematology
Zip code
390-0802
Address
3-1-1, Asahi, Matsumoto-shi, Nagano, 390-0802, Japan
TEL
0263-37-2554
Homepage URL
kaokos@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
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
Shinshu University
Address
3-1-1, Asahi, Matsumoto-shi, Nagano, 390-0802, Japan
Tel
0263-37-2554
mdrinri@shinshu-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
| 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
| 2024 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028548
