UMIN-CTR Clinical Trial

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 or GIF-XZ1200, 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 neoplasia 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 and the lesion is located at the irradiation field 4.The patients who take antithrombotic drug 5.The patients who are evaluated inappropriate for the research
Target sample size	44

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	Completed
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 10 Month 31 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	2021 Year 12 Month 04 Day

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