UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053833 |
|---|---|
| Receipt number | R000061442 |
| Scientific Title | Research on laryngeal mycosis in laryngeal symptoms |
| Date of disclosure of the study information | 2024/03/12 |
| Last modified on | 2024/03/12 11:32:04 |
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Basic information
Public title
Research on laryngeal mycosis in laryngeal symptoms
Acronym
Research on laryngeal mycosis
Scientific Title
Research on laryngeal mycosis in laryngeal symptoms
Scientific Title:Acronym
Research on laryngeal mycosis in laryngeal symptoms
Region
| Japan |
Condition
Condition
Patients complaining of abnormal laryngeal sensation
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of the relationship between abnormal laryngeal sensation and fungal colonization of the laryngeal mucosa
Basic objectives2
Others
Basic objectives -Others
Based on the concept of one airway, one disease in the airway, it is possible that fungal colonization may also be associated with the larynx. In this study, sputum and pharyngeal swab samples will be collected from patients who complain of laryngeal discomfort. Fungi will be isolated and cultured to investigate the relationship with fungal colonization in the laryngeal mucosa.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fungal expression in sputum and pharyngeal swabs
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
| 20 | years-old | <= |
Age-upper limit
| 89 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Select those that meet all of the selection criteria below. However, if it meets one or more of the exclusion criteria, it will be excluded.
(1) Patients with laryngeal symptoms who received treatment between the date of approval and December 31, 2024
(2) Patients who are able to obtain written consent for participation in the study from their own free will.
(3) Patients who are at least 20 years old and less than 90 years old at the time of obtaining consent
(4) Gender: Any gender
(5) Inpatients / outpatients: Outpatients
Key exclusion criteria
(1) Severe hepatic or renal dysfunction
(2) Pregnant patients
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Marie |
| Middle name | |
| Last name | Yamada |
Organization
International University of Health and Welfare Narita Nospital
Division name
Otorhinolaryngology, Head and Neck Surgery
Zip code
2868520
Address
852, Hatakeda, Narita, Chiba
TEL
0476355600
myamada@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Marie |
| Middle name | |
| Last name | Yamada |
Organization
International University of Health and Welfare Narita Nospital
Division name
Otorhinolaryngology, Head and Neck Surgery
Zip code
2868520
Address
852, Hatakeda, Narita, Chiba
TEL
0476355600
Homepage URL
myamada@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare Narita Nospital
Institute
Department
Personal name
Funding Source
Organization
International University of Health and Welfare Narita Nospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of International University of Health and Welfare, Chiba District
Address
852, Hatakeda, Narita, Chiba
Tel
0476355600
rinri_md@iuhw.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | 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
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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 09 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 28 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Laryngeal findings; observation of the laryngeal mucosa using a laryngeal fiberscope. Collection of sputum and pharyngeal swab. Blood test; fungus-specific IgE antibody titer, etc. Evaluation using the QOL questionnaire for cough and abnormal laryngeal sensation.
Management information
Registered date
| 2024 | Year | 03 | Month | 12 | Day |
Last modified on
| 2024 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061442
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
