UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Next generation sequencing diagnostics of relapsing/refractory acquired pure red cell aplasia in adults (PRCA-NGS2017 study)
Title of the study (Brief title)	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	Makoto Hirokawa
Organization	Akita University
Division name	Department of General Internal Medicine and Clinical Laboratory Medicine, Graduate School of Medicine
Address	1-1-1 Hondo, Akita 010-8543, Japan
TEL	018-884-6209
Email	mhirokawa@hos.akita-u.ac.jp

Public contact
Name of contact person	Makoto Hirokawa
Organization	Akita University
Division name	Department of General Internal Medicine and Clinical Laboratory Medicine, Graduate School of Medicin
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	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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2018 Year 05 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038624