UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056305 |
|---|---|
| Receipt number | R000064293 |
| Scientific Title | Measurement and observational study of cellular components in nasal lavage fluid to investigate the potential of nasal mucosa as a biomarker for evaluating the efficacy and safety of mucosal vaccines |
| Date of disclosure of the study information | 2024/12/02 |
| Last modified on | 2024/11/27 12:37:46 |
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Basic information
Public title
Establishing biomarkers for safety assessment through measurement and observational studies of cellular components in nasal mucosa
Acronym
Measurement and observation of cellular components in nasal mucosa
Scientific Title
Measurement and observational study of cellular components in nasal lavage fluid to investigate the potential of nasal mucosa as a biomarker for evaluating the efficacy and safety of mucosal vaccines
Scientific Title:Acronym
Biomarkers for the evaluation of efficacy and safety of mucosal vaccines
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To measure and analyze cellular components in samples of nasal lavage or nasopharyngeal swab fluid collected from study subjects, and to investigate their potential as biomarkers to help assess the efficacy and safety of nasal vaccines in clinical trials. In addition, in conjunction with information on blood cells, to analyse at a multi-omics level to gain a better understanding of the immune system in healthy individuals, and to investigate the relationship between this analytical information, genotypic information and the nasal flora.
Basic objectives2
Others
Basic objectives -Others
Bioanalysis
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation coefficient (Numerical value representing the correlation between parameters related to vaccination and biomarkers included in nasal mucosa)
Key secondary outcomes
S/B (Numerical value representing the accuracy of the assay system calculated as ratio of signal value to a background value, characterize nasal fluid)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Prescribe one hospital visit, and collect blood, upper respiratory tract specimens
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who have been fully informed about their participation in the study, and who have given their free and voluntary written consent based on a full understanding of the study.
Key exclusion criteria
Persons who fall into one of the following categories
1) who have used antibiotics within the past 10 weeks
2) Who have used proton pump inhibitors (drugs for treating hyperacidity or gastric ulcers) within the past 10 weeks
3) Pregnant women
4) Any other person deemed ineligible by the principal investigator or research assistant.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Kohtaro |
| Middle name | |
| Last name | Fujihashi |
Organization
Chiba University Hospital
Division name
Department of Human Mucosal Vaccinolog
Zip code
260-8670
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, 260-8670 Japan
TEL
043-222-7171
kfujihashi@chiba-u.jp
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Yamamoto |
Organization
Chiba University
Division name
Synergy institute for Futuristic Mucosal Vaccine Research and Development
Zip code
260-8677
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, 260-8677 Japan
TEL
043-226-2119
Homepage URL
wkyoten-suprtura02@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development, Strategic Center of Biomedical Advanced Vaccine Research and Development for Preparedness and Response (AMED SCARDA)
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
RIKEN
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba University Hospital Bioethics Review Board
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, 260-8677 Japan
Tel
043-222-7171
sp-seimei@chiba-u.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
千葉大学医学部附属病院 Chiba University Hospital
理化学研究所 RIKEN
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | Month | 02 | 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
| 2024 | Year | 09 | Month | 24 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 02 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 29 | Day |
Last modified on
| 2024 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064293
