UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008072 |
|---|---|
| Receipt number | 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 | 2020/12/06 13:05:33 |
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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 | 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
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
tokai.eso@tokai-u.jp
Sponsor or person
Institute
Department of Gastroenterological Surgery
Tokai University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009508
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
