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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024485
Receipt No. R000028047
Scientific Title Preliminary study of clinical performance of simultaneous quantification assay for cytomegalovirus DNA, Epstein-Barr DNA, and human herpesvirus 6 DNA
Date of disclosure of the study information 2016/10/31
Last modified on 2018/03/07

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Basic information
Public title Preliminary study of clinical performance of simultaneous quantification assay for cytomegalovirus DNA, Epstein-Barr DNA, and human herpesvirus 6 DNA
Acronym Clinical performance of quantification assay for CMV, EBV, and HHV6 DNA
Scientific Title Preliminary study of clinical performance of simultaneous quantification assay for cytomegalovirus DNA, Epstein-Barr DNA, and human herpesvirus 6 DNA
Scientific Title:Acronym 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
1st name
Middle name
Last name Hiroshi Kimura
Organization Nagoya University Graduate School of Medicine
Division name Department of Virology
Zip code
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
1st name
Middle name
Last name Hiroshi Kimura
Organization Nagoya University Graduate School of Medicine
Division name Department of Virology
Zip code
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)

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 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

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 Completed
Date of protocol fixation
2016 Year 09 Month 20 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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