UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036583 |
|---|---|
| Receipt number | R000041674 |
| Scientific Title | Identification of HPV related oropharyngeal precancerous lesions and establishment of their biomarkers |
| Date of disclosure of the study information | 2019/04/23 |
| Last modified on | 2024/04/29 11:13:19 |
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Basic information
Public title
Identification of HPV related oropharyngeal precancerous lesions and establishment of their biomarkers
Acronym
Identification of HPV related oropharyngeal precancerous lesions and establishment of their biomarkers
Scientific Title
Identification of HPV related oropharyngeal precancerous lesions and establishment of their biomarkers
Scientific Title:Acronym
Identification of HPV related oropharyngeal precancerous lesions and establishment of their biomarkers
Region
| Japan |
Condition
Condition
Cases of tonsillectomy for tonsillitis, IgA nephropathy and other benign diseases
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Identification of HPV related oropharyngeal precancerous lesions and establishment of their biomarkers
Basic objectives2
Others
Basic objectives -Others
Exploratory observational study to identify disease prevalence
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of precancerous lesions in target cases
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
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Cases of tonsillectomy for benign disease
Key exclusion criteria
No exclusion criteria
Target sample size
1200
Research contact person
Name of lead principal investigator
| 1st name | Hidenori |
| Middle name | |
| Last name | Inohara |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Otorhinolaryngology, Head and Neck Surgery
Zip code
565-0871
Address
2-2, Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3951
hinohara@ent.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Mori |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Otorhinolaryngology, Head and Neck Surgery
Zip code
565-0871
Address
2-2, Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3951
Homepage URL
mmori@ent.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University
Address
2-2, Yamadaoka, Suita, Osaka, 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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 04 | Month | 23 | 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
1180
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
| 2017 | Year | 10 | Month | 06 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 06 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 14 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2027 | Year | 03 | Month | 31 | Day |
Other
Other related information
It is a multicenter prospective observational study of 20 centers. The presence or absence of HPV-DNA is determined by gargle in cases that undergo tonsillectomy for benign diseases, and the presence or absence of precancerous lesions in excised tonsils is searched for high-risk HPV positive cases. Find out if there is a biomarker that can predict precancerous lesions in gargle or blood before surgery.
Management information
Registered date
| 2019 | Year | 04 | Month | 23 | Day |
Last modified on
| 2024 | Year | 04 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041674
