UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033866 |
|---|---|
| Receipt number | R000038624 |
| Scientific Title | Next generation sequencing diagnostics of relapsing/refractory acquired pure red cell aplasia in adults (PRCA-NGS2017 study) |
| Date of disclosure of the study information | 2018/09/01 |
| Last modified on | 2018/08/23 12:37:48 |
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Basic information
Public title
Next generation sequencing diagnostics of relapsing/refractory acquired pure red cell aplasia in adults (PRCA-NGS2017 study)
Acronym
NGS diagnostics in PRCA
Scientific Title
Next generation sequencing diagnostics of relapsing/refractory acquired pure red cell aplasia in adults (PRCA-NGS2017 study)
Scientific Title:Acronym
NGS diagnostics in PRCA
Region
| Japan |
Condition
Condition
acquired pure red cell aplasia (PRCA)
Classification by specialty
| Medicine in general | Hematology and clinical oncology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To identify the diagnostic biomarkers for relapsing/refractory acquired PRCA in adults by next generation sequencing of myeloid and lymphoid malignancy-associated genes.
Basic objectives2
Others
Basic objectives -Others
To identify the predictive biomarkers for efficacy of immunosuppressive therapy in acquired PRCA.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Not applicable
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
| 15 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Acquired pure red cell aplasia in adults
Key exclusion criteria
None
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Hirokawa |
Organization
Akita University
Division name
Department of General Internal Medicine and Clinical Laboratory Medicine, Graduate School of Medicine
Zip code
Address
1-1-1 Hondo, Akita 010-8543, Japan
TEL
018-884-6209
mhirokawa@hos.akita-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Hirokawa |
Organization
Akita University
Division name
Department of General Internal Medicine and Clinical Laboratory Medicine, Graduate School of Medicin
Zip code
Address
1-1-1 Hondo, Akita 010-8543, Japan
TEL
018-884-6209
Homepage URL
mhirokawa@hos.akita-u.ac.jp
Sponsor or person
Institute
Akita University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | Year | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 05 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 09 | 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
1. Somatic mutations of myeloid malignancy-associated genes
2. Somatic mutations of STAT3, STAT5B and A20 genes
3. TCR and BCR repertoires
4. Detection of PNH-type cells
Management information
Registered date
| 2018 | Year | 08 | Month | 23 | Day |
Last modified on
| 2018 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038624
