UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035126 |
|---|---|
| Receipt number | R000039265 |
| Scientific Title | Evaluation and optimization of newly developed blue-laser based technology for detection of malaria infection |
| Date of disclosure of the study information | 2018/12/04 |
| Last modified on | 2018/12/04 08:58:15 |
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Basic information
Public title
Evaluation and optimization of newly developed blue-laser based technology for detection of malaria infection
Acronym
Evaluation of blue-laser based technology for detection of malaria
Scientific Title
Evaluation and optimization of newly developed blue-laser based technology for detection of malaria infection
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Daisuke Usuda |
Organization
Kanazawa Medical University
Division name
Department of Infectious Diseases
Zip code
Address
1-1 Daigaku, Uchinada, Kahoku, Ishikawa
TEL
+220-7124878
usuda-d@kanazawa-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Usuda |
Organization
Kanazawa Medical University
Division name
Department of Infectious Diseases
Zip code
Address
1-1 Daigaku, Uchinada, Kahoku, Ishikawa
TEL
+220-7124878
Homepage URL
usuda-d@kanazawa-med.ac.jp
Sponsor or person
Institute
Medical Research Unit The Gambia at London School of Hygiene & Tropical Medicine
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Preinitiation
Date of protocol fixation
| 2018 | Year | 10 | Month | 01 | Day |
Date of IRB
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
Other
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
Value
https://center6.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 |
