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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name