UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048685 |
|---|---|
| Receipt number | R000055213 |
| Scientific Title | Evaluation of the usefulness of MPC polymers and PEG materials for immunochromatographic diagnostics. |
| Date of disclosure of the study information | 2022/09/12 |
| Last modified on | 2023/02/16 12:19:18 |
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Basic information
Public title
Evaluation of the usefulness of MPC polymers and PEG materials for immunochromatographic diagnostics.
Acronym
Evaluation of the usefulness of MPC polymers and PEG materials for immunochromatographic diagnostics.
Scientific Title
Evaluation of the usefulness of MPC polymers and PEG materials for immunochromatographic diagnostics.
Scientific Title:Acronym
Evaluation of the usefulness of MPC polymers and PEG materials for immunochromatographic diagnostics.
Region
| Japan |
Condition
Condition
Hepatitis B virus
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the usefulness of MPC polymers and PEG materials for adding to immunochromatographic diagnostics.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison of final detection sensitivity and specificity with additive use.
Key secondary outcomes
Comparison with CLEIA method
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are suspicious of HBV infection
Key exclusion criteria
No exclusion criteria
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Takako |
| Middle name | |
| Last name | Nakahara |
Organization
Kawasaki University of Medical Welfare
Division name
Department of Medical Technology Faculty of Health Science and Technology
Zip code
701-0193
Address
288 Matsushima, Kurashiki, Okayama
TEL
086-462-1111
tnakahara@jc.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Takako |
| Middle name | |
| Last name | Nakahara |
Organization
Kawasaki University of Medical Welfare
Division name
Department of Medical Technology Faculty of Health Science and Technology
Zip code
701-0193
Address
288 Matsushima, Kurashiki, Okayama
TEL
086-462-1111
Homepage URL
tnakahara@jc.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki University of Medical Welfare
Institute
Department
Personal name
Funding Source
Organization
NOF 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
Kawasaki University of Medical Welfare
Address
288 Matsushima, Kurashiki, Okayama
Tel
086-462-1111
tnakahara@jc.kawasaki-m.ac.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
川崎医療福祉大学（岡山県）、川崎医科大学附属病院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | Month | 12 | 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
174
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 08 | Month | 17 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 06 | Month | 30 | Day |
Other
Other related information
All patients who underwent blood tests at Kawasaki Medical School Hospital between June 20 and October 31, 2022 and met the selection criteria.
Approximately 2 mL of serum from the remaining specimens of blood specimens collected for medical treatment is used for the purpose of measuring HBs antigen.
Management information
Registered date
| 2022 | Year | 08 | Month | 17 | Day |
Last modified on
| 2023 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055213
