UMIN-CTR Clinical Trial

Basic information
Public title	Multi-omics analysis of esophageal cancer for elucidating carcinogenic mechanisms and identifying diagnostic markers
Acronym	Multi-omics analysis of esophageal cancer
Scientific Title	Multi-omics analysis of esophageal cancer for elucidating carcinogenic mechanisms and identifying diagnostic markers
Scientific Title:Acronym	Multi-omics analysis of esophageal cancer
Region	Japan

Condition
Condition	esophageal cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	Omics-based analysis of esophageal cancer for investigating carcinogenesis mechanism and detecting diagnostic markers
Basic objectives2	Others
Basic objectives -Others	Omics-based analysis of esophageal cancer for investigating carcinogenesis mechanism and detecting diagnostic markers
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Relationship between results of omics-based analysis and cliniophathological factors
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	Patient who will undergo radical surgery Patient who gives his/her informed consent to participating in this research Patient whose tumor is large enough for pathological diagnosis after collecting sample
Key exclusion criteria	Patient whose HBs-Ag test, HCV-Ab test , or TPHA test is positive Patient who has received steroids systemically Patient who suffers from systemic infectious disease Patient who suffers from active multiple primary cancers Patient who has no ability to judge
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Soji Middle name Last name Ozawa
Organization	Tokai University School of Medicine
Division name	Department of Gastroenterological Surgery
Zip code	259-1193
Address	143 Shimokasuya, Isehara, Kanagawa, 259-1193
TEL	0463-93-1121
Email	sozawa@tokai.ac.jp

Public contact
Name of contact person	1st name Soji Middle name Last name Ozawa
Organization	Tokai University School of Medicine
Division name	Department of Gastroenterological Surgery
Zip code	259-1193
Address	143 Shimokasuya, Isehara, Kanagawa, 259-1193
TEL	0463-93-1121
Homepage URL
Email	tokai.eso@tokai-u.jp

Sponsor
Institute	Department of Gastroenterological Surgery Tokai University School of Medicine
Institute
Department

Funding Source
Organization	Department of Gastroenterological Surgery Tokai University School of Medicine
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	Institutional Review Board for Clinical Research, Tokai University
Address	Shimokasuya 143, Isehara, Kanagawa, JAPAN
Tel	0463-93-1121
Email	tokai-rinsho@ml.tokai-u.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	東海大学医学部付属病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2012 Year 05 Month 31 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	2012 Year 02 Month 15 Day
Date of IRB	2012 Year 04 Month 27 Day
Anticipated trial start date	2012 Year 05 Month 01 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The registration stared in May 2012.

Management information
Registered date	2012 Year 05 Month 31 Day
Last modified on	2020 Year 12 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009508