UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062285 |
|---|---|
| Receipt number | R000071252 |
| Scientific Title | A Multicenter Observational Study on Screening for Early HPV-Related Tonsillar Lesions Using High-Risk HPV mRNA in Gargle Samples |
| Date of disclosure of the study information | 2026/07/21 |
| Last modified on | 2026/07/21 10:51:50 |
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Basic information
Public title
A Multicenter Study Using Gargle Samples to Detect Early HPV-Related Tonsillar Lesions
Acronym
Gargle-HPV-Tonsil Study
Scientific Title
A Multicenter Observational Study on Screening for Early HPV-Related Tonsillar Lesions Using High-Risk HPV mRNA in Gargle Samples
Scientific Title:Acronym
Gargle-HPV-Tonsil Study
Region
| Japan |
Condition
Condition
HPV-related early tonsillar lesions, including HPV-related precancerous lesions and early-stage cancer
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To identify HPV-related precancerous lesions and early-stage cancer, collectively defined as HPV-related early tonsillar lesions, in resected tonsils from patients undergoing tonsillectomy for benign diseases, and to determine the diagnostic performance of high-risk HPV E6/E7 mRNA in preoperative gargle samples by comparing the assay results with the presence or absence of HPV-related early tonsillar lesions.
Basic objectives2
Others
Basic objectives -Others
Evaluation of the diagnostic performance of a screening biomarker
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Diagnostic performance of high-risk HPV E6/E7 mRNA in preoperative gargle samples for detecting HPV-related early tonsillar lesions.
Key secondary outcomes
Prevalence of pharyngeal HPV infection among patients undergoing tonsillectomy for benign diseases, as assessed by HPV DNA testing of preoperative gargle samples.
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
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who meet all of the following criteria are eligible:
1. Patients scheduled to undergo tonsillectomy for a benign disease
2. Eastern Cooperative Oncology Group Performance Status of 0 or 1
3. Age 18 years or older and younger than 85 years at the time of informed consent
4. Written informed consent to participate in the study provided by the patient
Key exclusion criteria
Patients who meet any of the following criteria will be excluded:
1. A history of bilateral tonsillectomy or radiotherapy to the oropharynx
2. A psychiatric disorder or psychiatric symptoms that interfere with daily activities and make participation in the study difficult
3. Patients considered unsuitable for participation in the study by the investigator for any other reason
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Hidenori |
| Middle name | |
| Last name | Inohara |
Organization
The University of Osaka Graduate School of Medicine
Division name
Department of Otorhinolaryngology-Head and Neck Surgery
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL
06-6879-3951
hinohara@ent.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Tadashi |
| Middle name | |
| Last name | Yoshii |
Organization
The University of Osaka Graduate School of Medicine
Division name
Department of Otorhinolaryngology-Head and Neck Surgery
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL
06-6879-3951
Homepage URL
https://www.med.osaka-u.ac.jp/pub/ent/speciality/tumor.html
tyoshii@ent.osaka-u.ac.jp
Sponsor or person
Institute
The University of Osaka
Institute
Department
Personal name
Funding Source
Organization
The University of Osaka
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The University of Osaka Hospital Ethical Review Board
Address
The University of Osaka Hospital, 4th Floor, Center of Medical Innovation and Translational Research Building, 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan
Tel
06-6210-8296
rinri@hp-crc.med.osaka-u.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
大阪大学医学部附属病院（大阪府）
市立吹田市民病院（大阪府）
市立豊中病院（大阪府）
市立池田病院（大阪府）
箕面市立病院（大阪府）
大阪急性期・総合医療センター（大阪府）
大阪医療センター（大阪府）
住友病院（大阪府）
大手前病院（大阪府）
大阪けいさつ病院（大阪府）
大阪ろうさい病院（大阪府）
八尾市立病院（大阪府）
市立東大阪医療センター（大阪府）
堺市立総合医療センター（大阪府）
大阪はびきの医療センター（大阪府）
関西ろうさい病院（兵庫県）
県立西宮総合医療センター（兵庫県）
関西メディカル病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 21 | Day |
Related information
URL releasing protocol
https://www.med.osaka-u.ac.jp/pub/ent/speciality/tumor.html
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
270
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
No plan to share individual participant data (IPD).
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 06 | Month | 23 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 24 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 18 | Day |
Last follow-up date
| 2029 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Participant enrollment began on November 18, 2025. The study was retrospectively registered with the UMIN Clinical Trials Registry after it was identified that trial registration had not been completed before enrollment.
Management information
Registered date
| 2026 | Year | 07 | Month | 21 | Day |
Last modified on
| 2026 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071252
