UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Subtype Classification Consortium for Esophageal Squamous cell carcinoma Sensitivity
Title of the study (Brief title)	SUCCESS study
Region	Japan

Condition
Condition	Esophageal cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To do subtype classification of esophageal cancer by profiling the 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 esophageal cancer
Key secondary outcomes	Correlation between subtype classification and curative effects

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 was diagnosed newly with esophageal cancer, and will undergo a surgical treatment, radiotherapy or chemoradiotherapy. 2)Patients aged >= 20 years. 3)Written informed consent.
Key exclusion criteria	1)Patients have received systemic chemotherapy. 2)Patients have undergone chest and mediastinum radiotherapy. 3)Patients have HBs antigen or HCV antibody 4)Patients is taking an antiplatelet agent or anticoagulant agent 5)Patients have too small esophageal cancer 6)Patients are pregnant or lactating women. 7)Patients are not suitable for this study.
Target sample size	300

Research contact person
Name of lead principal investigator	Manabu Muto
Organization	Kyoto university hospital
Division name	Clinical Oncology
Address	54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto 606-8507, Japan
TEL	075-751-4592
Email	mmuto@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Yusuke Amanuma
Organization	Kyoto university hospital
Division name	Clinical Oncology
Address	54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto 606-8507, Japan
TEL	075-751-3518
Homepage URL
Email	yusuke12@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto university hospital
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	京都大学医学部附属病院（京都府）、国立がん研究センター研究所（東京都）、近畿大学医学部附属病院（大阪府）、川崎医科大学附属病院（岡山県）、大阪府立成人病センター（大阪府）、長崎大学病院（長崎県）、国立がん研究センター東病院（千葉県）、北里大学病院（神奈川県）、富山大学附属病院（富山県）、千葉県がんセンター（千葉県）、石川県立中央病院（石川県）

Other administrative information
Date of disclosure of the study information	2015 Year 03 Month 01 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2014 Year 12 Month 17 Day
Anticipated trial start date	2015 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	A multicenter prospective observational study

Management information
Registered date	2015 Year 01 Month 06 Day
Last modified on	2018 Year 01 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018724