UMIN-CTR Clinical Trial

Basic information
Public title	Subtype classification of superficial esophageal cancer from gene expression profile
Acronym	Subtype classification of superficial esophageal cancer
Scientific Title	Subtype classification of superficial esophageal cancer from gene expression profile
Scientific Title:Acronym	Subtype classification of superficial esophageal cancer
Region	Japan

Condition
Condition	superficial esophageal cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To classify superficial esophageal cancer based on risk factors, endoscopic characteristics and gene expression of pretreatment biopsy sample
Basic objectives2	Others
Basic objectives -Others	prospective cohort study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Subtype classification of superficial esophageal cancer based on gene expression profiles, risk factors and endoscopic characteristics
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Patients with superficial esophageal cancer who will undergo endoscopic resection, surgery or chemoradiotherapy 2)Squamous cell carcinoma 3)Written informed consent is obtained
Key exclusion criteria	1)Adenocarcinoma, small cell carcinoma or neuroendocrine carcinoma 2)Patients who have history of chemotherapy 3)Patients who have history of radiation therapy to the chest or mediastinum 4)Patients who have received antiplatelet agent or anticoagulation agent 5)Patients who have too small superficial esophageal cancer to take biopsy sample 6)Patient who are pregnant 7)Patients who have been judged as in appropriate for this study
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Ryu Ishihara
Organization	Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name	Department of Gastrointestinal Oncology
Zip code
Address	1-3-3, Higashinari-ku, Osaka 537-8511, Japan
TEL	+81-6-6972-1181
Email	isihara-ry@mc.pref.osaka.jp

Public contact
Name of contact person	1st name Middle name Last name Yasushi Yamasaki
Organization	Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name	Department of Gastrointestinal Oncology
Zip code
Address	1-3-3, Higashinari-ku, Osaka 537-8511, Japan
TEL	+81-6-6972-1181
Homepage URL
Email	yamazaki-ya@mc.pref.osaka.jp

Sponsor
Institute	Osaka Medical Center for Cancer and Cardiovascular Diseases
Institute
Department

Funding Source
Organization	Not yet confirmed
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	National Cancer Center Research Institute
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	大阪府立成人病センター（大阪府）、国立がん研究センター研究所（東京都）

Other administrative information
Date of disclosure of the study information	2015 Year 04 Month 19 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	No longer recruiting
Date of protocol fixation	2015 Year 03 Month 23 Day
Date of IRB	2015 Year 03 Month 23 Day
Anticipated trial start date	2015 Year 04 Month 20 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	prospective observational study

Management information
Registered date	2015 Year 04 Month 19 Day
Last modified on	2020 Year 04 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019925