UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032349 |
|---|---|
| Receipt number | R000036823 |
| Scientific Title | Diagnosis of HHV-6 infection using real-time PCR method |
| Date of disclosure of the study information | 2018/06/01 |
| Last modified on | 2021/04/25 11:40:58 |
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Basic information
Public title
Diagnosis of HHV-6 infection using real-time PCR method
Acronym
Diagnosis of HHV-6 infection using real-time PCR method
Scientific Title
Diagnosis of HHV-6 infection using real-time PCR method
Scientific Title:Acronym
Diagnosis of HHV-6 infection using real-time PCR method
Region
| Japan |
Condition
Condition
Recipients of allogeneic stem cell transplantation, including bone marrow, peripheral blood, or cord blood transplantation
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
For estimating the abilities of real-time PCR method for the diagnosis, evaluating the severity of disease, and judging the treatment effectiveness of HHV-6-associated diseases, especially HHV-6 encephalitis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Positive rate for HHV-6 DNA
Key secondary outcomes
1. Antiviral agents
2. Association between the results of blood HHV-6 DNA and the development of HHV-6 encephalitis
3. Sensitivity, specificity, positive predictive value, and negative predictive value of positive results for HHV-6 DNA for the diagnosis of HHV-6 encephalitis
4. Association between the results of HHV-6 DNA in cerebrospinal fluid and the development of HHV-6 encephalitis
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
| 16 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Recipients of allogeneic stem cell transplantation treated in our hospital
Key exclusion criteria
Patients who didn't agree to participation and patients who were judged as inadequate to participate in this study by the opinion of the investigators.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masao |
| Middle name | |
| Last name | Ogata |
Organization
Oita University Hospital
Division name
Hematology
Zip code
8795593
Address
Hasama-Machi, Yufu-City
TEL
097-549-4411
mogata@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | Masao |
| Middle name | |
| Last name | Ogata |
Organization
Oita University Hospital
Division name
Hematology
Zip code
8795593
Address
Hasama-Machi, Yufu-City
TEL
097-549-4411
Homepage URL
mogata@oita-u.ac.jp
Sponsor or person
Institute
Department of Hematology, Oita University Hospital.
Institute
Department
Personal name
Funding Source
Organization
Oita University
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
Oita University
Address
Hasama-machi, Oita
Tel
097-549-4411
mogata@oita-u.ac.jp
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 | 06 | 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
0
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
| 2018 | Year | 04 | Month | 16 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 16 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We are planning to apply this study protocol to "Senshin Iryou A" (Advanced medical treatment A).
After obtaining approval by the Ministry (Kyushu Regional Bureau of Health and Welfare), this study will be performed as advanced medical treatment A.
Management information
Registered date
| 2018 | Year | 04 | Month | 23 | Day |
Last modified on
| 2021 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036823
