UMIN-CTR Clinical Trial

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
Email	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
Email	mogata@oita-u.ac.jp

Sponsor
Institute	Department of Hematology, Oita University Hospital.
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036823