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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036583
Receipt No. 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 2019/04/23

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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 2000

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
Email hinohara@ent.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name Hidenori
Middle name
Last name Tanaka
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
Email htanaka@ent.med.osaka-u.ac.jp

Sponsor
Institute Osaka University
Institute
Department

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
Email handai-nintei@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
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
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
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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
2019 Year 04 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041674

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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