UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024485 |
|---|---|
| Receipt number | 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 13:18:26 |
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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
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
multiplex@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028047
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
