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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000008072
Receipt No. R000009508
Scientific Title Multi-omics analysis of esophageal cancer for elucidating carcinogenic mechanisms and identifying diagnostic markers
Date of disclosure of the study information 2012/05/31
Last modified on 2016/06/13

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

Public contact
Name of contact person
1st name
Middle name
Last name Soji Ozawa
Organization Tokai University School of Medicine
Division name Department of Gastroenterological Surgery
Zip code
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
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 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 Enrolling by invitation
Date of protocol fixation
2012 Year 02 Month 15 Day
Date of IRB
Anticipated trial start date
2012 Year 05 Month 01 Day
Last follow-up date
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
2016 Year 06 Month 13 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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