UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Preliminary study of clinical performance of simultaneous quantification assay for cytomegalovirus DNA, Epstein-Barr DNA, and human herpesvirus 6 DNA
Title of the study (Brief title)	Clinical performance of quantification assay for CMV, EBV, and HHV6 DNA
Region	Japan

Condition
Condition	Stem cell transplantation
Classification by specialty	Hematology and clinical oncology Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To study clinical performance of a newly developed assay kit for quantifying CMV, EBV, HHV6 DNA
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	This kit will be used for quantifying CMV, EBV, HHV6 DNA in peripheral blood of transplanted patients in order to evaluate clinical performance of the kit in comparison with a home brew kit of Nagoya University and calculating correlation coefficient.
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	1 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) recipients of stem cell transplantation 2) recipients and/or their parents or legal guardians who are willing and able to give signed consent
Key exclusion criteria	recipients whom the investigator deemed ineligible to this study
Target sample size	30

Research contact person
Name of lead principal investigator	Hiroshi Kimura
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Virology
Address	65 Tsurumai-cho, Showa-ku, Nagoya 466-8550
TEL	052-744-2450
Email	hkimura@med.nagoya-u.ac.jp

Public contact
Name of contact person	Hiroshi Kimura
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Virology
Address	65 Tsurumai-cho, Showa-ku, Nagoya 466-8550
TEL	052-744-2450
Homepage URL
Email	multiplex@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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	名古屋大学医学部附属病院（愛知県） 藤田保健衛生大学医学部附属病院（愛知県） 名古屋第一赤十字病院（愛知県） 国家公務員共済組合連合会　虎の門病院（東京都）

Other administrative information
Date of disclosure of the study information	2016 Year 10 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 09 Month 20 Day
Anticipated trial start date	2016 Year 11 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	To evaluate the presence of each viral infection, following information is scheduled to be collected from medical records. 1) Sex/ Age 2) Transplantation information 3) Complications 4) Pathological findings 5) Imaging finding 6) Therapies against viral infections 7) Laboratory tests 8) CMV pp65 9) Flow cytometry 10) Clinical findings related with each viral infection

Management information
Registered date	2016 Year 10 Month 19 Day
Last modified on	2018 Year 03 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028047