UMIN-CTR Clinical Trial

Basic information
Public title	prospective study of endoscopic evaluation for invasion depth of superficial esophageal cancers
Acronym	endoscopic evaluation for invasion depth of superficial esophageal cancers
Scientific Title	prospective study of endoscopic evaluation for invasion depth of superficial esophageal cancers
Scientific Title:Acronym	endoscopic evaluation for invasion depth of superficial esophageal cancers
Region	Japan

Condition
Condition	superficial esophageal cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	to evaluate the accuracy of the diagnosis of invasion depth in superficial esophageal SCC evaluated by Endoscopy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	accuracy rate of the diagnosis of invasion depth of the superficial esophageal SCC according to JES Classification
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. The patients who have a superficial esophageal SCC 2. Patients who underwent high definition endoscopic diagnosis for esophageal SCC 3. Patients who underwent image enhanced endoscopy for esophageal SCC
Key exclusion criteria	1.The patients treated by chemotherapy or radiotherapy for esophageal SCC 2. The patients treated by chemotherapy before resection of esophageal SCC 3.The patients who had been treated by chemotherapy or radiotherapy for esophageal SCC 4.The patients who have a severe underlying disease
Target sample size	600

Research contact person
Name of lead principal investigator	1st name Hiroyuki Middle name Last name Okada
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Department of Gastroenterology and Hepatology
Zip code	700-8558
Address	2-5-1 Shikata, Okayama 700-8558, Japan
TEL	086-235-7218
Email	hiro@md.okayama-u.ac.jp

Public contact
Name of contact person	1st name Keisuke Middle name Last name Hori
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Department of Gastroenterology and Hepatology
Zip code	700-8558
Address	2-5-1 Shikata, Okayama 700-8558, Japan
TEL	086-235-7218
Homepage URL
Email	hori-kei@okayama-u.ac.jp

Sponsor
Institute	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Department of Gastroenterology and Hepatology
Institute
Department

Funding Source
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Department of Gastroenterology and Hepatology
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	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Address	2-5-1 Shikata, Okayama 700-8558, Japan
Tel	086-235-6503
Email	mae6605@adm.okayama-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	2015 Year 10 Month 13 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	Preinitiation
Date of protocol fixation	2015 Year 04 Month 28 Day
Date of IRB
Anticipated trial start date	2015 Year 10 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Prospective observational study for accuracy rate of the diagnosis of invasion depth of the superficial esophageal SCC according to JES Classification, in comparison with the accuracy of the invasion depth under non magnifying white light image.

Management information
Registered date	2015 Year 10 Month 12 Day
Last modified on	2020 Year 06 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022226