UMIN-CTR Clinical Trial

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
Email	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
Email	oka@acc.ncgm.go.jp

Sponsor
Institute	National Center for Global Health and Medicine
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051152