UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044865 |
|---|---|
| Receipt number | R000051152 |
| Scientific Title | Usefulness of the HIV-antigen/antibody detecting screening test kit by using dried blood spot samples |
| Date of disclosure of the study information | 2021/07/15 |
| Last modified on | 2022/01/04 10:34:13 |
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Basic information
Public title
Usefulness of the HIV-antigen/antibody detecting screening test kit by using dried blood spot samples
Acronym
DBS study
Scientific Title
Usefulness of the HIV-antigen/antibody detecting screening test kit by using dried blood spot samples
Scientific Title:Acronym
DBS study
Region
| Japan |
Condition
Condition
HIV infection
Classification by specialty
| Infectious disease | Laboratory medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate usefulness of dried blood spot samples on Lumiplus HIV Ag/Ab test kit
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To examine sensitivity and specificity of Lumiplus test by using dried blood spot samples
Key secondary outcomes
To determine the cut off value of Lumiplus test by using dried blood spot samples
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)Age of 20 years or older person who have obtained written consent in the study.
(2)Person who diagnosed HIV infection and non-HIV infection
Key exclusion criteria
(1)Person whose physicians consider the study enrollment inappropriate.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Shinichi |
| Middle name | |
| Last name | Oka |
Organization
National Center for Global Health and Medicine
Division name
AIDS Clinical Center
Zip code
162-8655
Address
Toyama 1-21-1, Shinjuku-ku, Tokyo
TEL
03-3202-7181
oka@acc.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Shinichi |
| Middle name | |
| Last name | Oka |
Organization
National Center for Global Health and Medicine
Division name
AIDS Clinical Center
Zip code
162-8655
Address
Toyama 1-21-1, Shinjuku-ku, Tokyo
TEL
03-3202-7181
Homepage URL
oka@acc.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
FUJIREBIO Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
FUJIREBIO Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Division of Medical Research Management, Management and Planning Bureau National Center for Global Health and Medicine
Address
Toyama 1-21-1, Shinjuku-ku, Tokyo
Tel
03-3202-7181
rinrijm@hosp.ncgm.go.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
国立研究開発法人 国立国際医療研究センター, 富士レビオ株式会社
National Center for Global Health and Medicine, FUJIREBIO Inc.
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 07 | Month | 15 | 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
| 2021 | Year | 07 | Month | 14 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 14 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To investigate usefulness of dried blood spot samples on Lumiplus HIV Ag/Ab test kit
Management information
Registered date
| 2021 | Year | 07 | Month | 14 | Day |
Last modified on
| 2022 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051152
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
