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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000035126 |
Receipt No. | R000039265 |
Official scientific title of the study | 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 |
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 |
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Condition | ||
Condition | Malaria (Plasmodium falciparum) | |
Classification by specialty |
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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 |
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Age-upper limit |
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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 |
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Key exclusion criteria | 1. Patients with severe malaria
2. Subjects deemed not suitable for the study at the discretion of the investigator |
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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 |
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 | |
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 |
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Progress | |||||||
Recruitment status | Preinitiation | ||||||
Date of protocol fixation |
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Anticipated trial start date |
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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 |
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Last modified on |
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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 |