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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036292
Receipt No. R000041344
Scientific Title Investigation of laryngopharynx and oral disease on upper gastrointestinal endoscopy
Date of disclosure of the study information 2019/03/26
Last modified on 2019/03/25

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Basic information
Public title Investigation of laryngopharynx and oral disease on upper gastrointestinal endoscopy
Acronym Investigation of laryngopharynx and oral disease on upper gastrointestinal endoscopy
Scientific Title Investigation of laryngopharynx and oral disease on upper gastrointestinal endoscopy
Scientific Title:Acronym Investigation of laryngopharynx and oral disease on upper gastrointestinal endoscopy
Region
Japan

Condition
Condition laryngopharynx and oral disease
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 In upper gastrointestinal endoscopy, we investigate the status of detection and diagnosis of laryngopharynx and oral disease including mainly cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Rate that required consultation to otorhinolaryngologist, detection rate of laryngopharynx and oral cancer, and false positive rate for laryngopharynx and oral cancer.
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
18 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria Participant who underwent upper gastrointestinal endoscopy for screening.
Key exclusion criteria None.
Target sample size 50000

Research contact person
Name of lead principal investigator
1st name Majima
Middle name
Last name Kenichiro
Organization Kameda Medical Center
Division name Department of Health Management
Zip code 296-8602
Address 929 Higashi-cho, Kamogawa City, Chiba Prefecture, Japan
TEL 04-7092-2211
Email majiken@hotmail.com

Public contact
Name of contact person
1st name Majima
Middle name
Last name Kenichiro
Organization Kameda Medical Center
Division name Department of Health Management
Zip code 296-8602
Address 929 Higashi-cho, Kamogawa City, Chiba Prefecture, Japan
TEL 04-7092-2211
Homepage URL
Email majiken@hotmail.com

Sponsor
Institute Kameda Medical Center
Institute
Department

Funding Source
Organization None
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 Kameda General Hospital Clinical Research Review Committee Office
Address 929 Higashi-cho, Kamogawa City, Chiba Prefecture, Japan
Tel 04-7092-2211
Email I can not publish it.

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 03 Month 26 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 51628
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
2019 Year 02 Month 21 Day
Date of IRB
2019 Year 02 Month 21 Day
Anticipated trial start date
2019 Year 02 Month 22 Day
Last follow-up date
2019 Year 03 Month 18 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2019 Year 03 Month 25 Day
Last modified on
2019 Year 03 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041344

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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