UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation and optimization of newly developed blue-laser based technology for detection of malaria infection
Title of the study (Brief title)	Evaluation of blue-laser based technology for detection of malaria
Region	Africa

Condition
Condition	Malaria (Plasmodium falciparum)
Classification by specialty	Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Primary: To compare XN-30 sensitivity and specificity with those of MS and RDT (To determine the sensitivity and specificity of XN-30 for malaria detection in suspected clinical malaria cases) (To determine the sensitivity and specificity of XN-30 for malaria detection in asymptomatic, malaria-infected carriers) Secondary: To estimate the effect of length of sample storage and of temperature on XN-30's performances
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Sensitivity and specificity of XN-30 as compared to those of MS and RDT in suspected clinical cases and in randomly selected individuals
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	6 months-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	For suspected clinical cases: 1. Age >= 6 months 2. Patients attending Basse Hospital with suspected malaria 3. Fever (axillary temperature >= 37.5) or history of fever in the last 48 hours 4. Provision of informed consent (parents or guardians for minors) and assent for participants 12-17 years old For the malariometric survey 1. Age >= 6 months 2. People of the general population with unknown malaria status 3. Provision of informed consent and assent for participants 12-17 years 4. Provision of informed consent (parents or guardians for minors) and assent for participants 12-17 years old
Key exclusion criteria	1. Patients with severe malaria 2. Subjects deemed not suitable for the study at the discretion of the investigator
Target sample size	505

Research contact person
Name of lead principal investigator	Daisuke Usuda
Organization	Kanazawa Medical University
Division name	Department of Infectious Diseases
Address	1-1 Daigaku, Uchinada, Kahoku, Ishikawa
TEL	+220-7124878
Email	usuda-d@kanazawa-med.ac.jp

Public contact
Name of contact person	Daisuke Usuda
Organization	Kanazawa Medical University
Division name	Department of Infectious Diseases
Address	1-1 Daigaku, Uchinada, Kahoku, Ishikawa
TEL	+220-7124878
Homepage URL
Email	usuda-d@kanazawa-med.ac.jp

Sponsor
Institute	Medical Research Unit The Gambia at London School of Hygiene & Tropical Medicine
Institute
Department

Funding Source
Organization	Sysmex Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	Medical Research Unit The Gambia at London School of Hygiene & Tropical Medicine

Other administrative information
Date of disclosure of the study information	2018 Year 12 Month 04 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 10 Month 01 Day
Anticipated trial start date	2018 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	XN-30's performance in detection malaria had been confirmed by basic experiment.

Management information
Registered date	2018 Year 12 Month 04 Day
Last modified on	2018 Year 12 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039265

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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