UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037959 |
|---|---|
| Receipt number | R000043254 |
| Scientific Title | Mouthwash- based HPV detection |
| Date of disclosure of the study information | 2019/09/07 |
| Last modified on | 2021/10/06 13:46:58 |
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Basic information
Public title
Mouthwash- based HPV detection
Acronym
HPV detection
Scientific Title
Mouthwash- based HPV detection
Scientific Title:Acronym
HPV detection
Region
| Japan |
Condition
Condition
HPV Infections
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Identify the 9 genotypes of HPV by pyrosequencing using mouthwash waste fluids
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Compare between mouthwash- based HPV detection method and conventional method
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who underwent otolaryngoscopic examination with a mouthwash pretreatment at the Toho University Hospital (Tokyo, Japan)
Key exclusion criteria
No exclusion criteria
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | Yukiko |
| Middle name | |
| Last name | Seto |
Organization
Toho University Omori Medical Center
Division name
Department of Otolaryngology
Zip code
143-8541
Address
6-11-1 Omori-nishi, Ota-ku, Tokyo, Japan
TEL
03-3762-4151
setoyukiko@mac.com
Public contact
Name of contact person
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Watanabe |
Organization
Kawasaki Rinko General Hospital
Division name
Department of Internal Medicine
Zip code
210-0806
Address
3-13-1 Nakajima, Kawasaki-ku, Kawasaki-city, Kanagawa, Japan
TEL
044-233-9336
Homepage URL
ponponta@marianna-u.ac.jp
Sponsor or person
Institute
Toho University Omori Medical Center
Institute
Department
Personal name
Funding Source
Organization
Toho University Omori Medical Center
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toho University Omori Medical Center
Address
6-11-1 Omori-nishi, Ota-ku, Tokyo, Japan
Tel
03-3762-4151
setoyukiko@mac.com
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
東邦大学医療センター大森病院
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 07 | Day |
Related information
URL releasing protocol
now submitting
Publication of results
Unpublished
Result
URL related to results and publications
now submitting
Number of participants that the trial has enrolled
52
Results
We finally could identify the 9 genotypes of HPV targeted for vaccination by pyrosequencing using mouthwash waste fluids (n=52), because of we found only the specific unique reverse sequencing probe (Pyro-Genotyping). A relatively high rate of mouthwash waste fluids testing positive for HPV was determined, which was 11/52 (21.2%, genotype 6; n=1, 11; n=1, 16; n=1, and 18; n=8). These results had surpassed the results obtained from the same specimens using the conventional method (1 /52, 1.9%).
Results date posted
| 2020 | Year | 03 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Total 52 samples of the mixed oral cleaning fluid (mouthwash waste fluids) from the waste tank were collected from patients who underwent otolaryngoscopic examination with a mouthwash pretreatment at the Toho University Hospital (Tokyo, Japan) from April 2018 to December 2018.
Participant flow
no relation of patient flow
Adverse events
NONE
Outcome measures
Compare between our method (pyrosequencing based HPV genotyping) and conventional method.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 17 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 17 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2019 | Year | 09 | Month | 07 | Day |
Last modified on
| 2021 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043254
| 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 |
