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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000042428
Receipt No. R000047772
Scientific Title Usability of an ultra-thin endoscopy for diagnosing superficial squamous neoplasms in the pharynx and esophagus : a prospective trial
Date of disclosure of the study information 2020/11/12
Last modified on 2020/11/12

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Basic information
Public title Usability of an ultra-thin endoscopy for diagnosing pharyngeal and esophageal cancer
Acronym Diagnosis of pharyngeal and esophageal cancer using an ultra-thin endoscopy
Scientific Title Usability of an ultra-thin endoscopy for diagnosing superficial squamous neoplasms in the pharynx and esophagus : a prospective trial
Scientific Title:Acronym Diagnosis of superficial squamous neoplasms in the pharynx and esophagus using an ultra-thin endoscope
Region
Japan

Condition
Condition superficial squamous neoplasms in the pharynx and esophagus
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Usability of an ultra-thin endoscopy for diagnosing pharyngeal and esophageal cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Rate of concordance in diagnosing superficial pharyngeal or esophageal cancer using an ultra-thin endoscopy and magnified endoscopy
Key secondary outcomes 1. Inter- and intra-observer agreement for diagnosing superficial pharyngeal and esophageal cancer

2. Diagnostic accuracy of an ultra-thin endoscopy and magnified endoscopy for superficial pharyngeal or esophageal cancer

3. Comparison of visibility for superficial pharyngeal and esophageal cancer using an ultra-thin endoscopy and magnified endoscopy

4. Characteristics of undetectable superficial pharyngeal or esophageal cancer using ultra-thin endoscopy

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 Two endoscopes will be used in this study (GIF-1200N and GIF-EZ1500, Olympus).
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. The patients with present history of superficial pharyngeal or esophageal cancer

2. The patients who agree with the informed consent
Key exclusion criteria 1.A Patient aged < 20
2. A patient who is pregnant
3.The patients who have history of radiotherapy for esophageal cancer
4.The patients who take antithrombotic drug
5.The patients who are evaluated inappropriate for the research
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Akira
Middle name
Last name Dobashi
Organization The Jikei University School of Medicine
Division name Department of Endoscopy
Zip code 1058461
Address 3-25-8 Nishishimbashi
TEL 03-0344-1111
Email ad99061@jikei.ac.jp

Public contact
Name of contact person
1st name Akira
Middle name
Last name Dobashi
Organization The Jikei University School of Medicine
Division name Department of Endoscopy
Zip code 1058461
Address 3-25-8 Nishishimbashi
TEL 03-3433-1111
Homepage URL
Email ad99061@jikei.ac.jp

Sponsor
Institute The Jikei University School of Medicine
Institute
Department

Funding Source
Organization Research fund of The Jikei University School of Medicine, Department of Endoscopy
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 The Jikei University School of Medicine
Address 3-25-8 Nishi-shimbashi, Minato-ku, Tokyo
Tel 03-3433-1111
Email rinri@jikei.ac.jp

Secondary IDs
Secondary IDs YES
Study ID_1 32-157(10238)
Org. issuing International ID_1 32-157(10238)
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 東京慈恵会医科大学附属病院

Other administrative information
Date of disclosure of the study information
2020 Year 11 Month 12 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 Enrolling by invitation
Date of protocol fixation
2020 Year 09 Month 14 Day
Date of IRB
2020 Year 09 Month 14 Day
Anticipated trial start date
2020 Year 10 Month 01 Day
Last follow-up date
2021 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 11 Month 12 Day
Last modified on
2020 Year 11 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047772

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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