UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016141 |
|---|---|
| Receipt number | R000018724 |
| Scientific Title | Subtype Classification Consortium for Esophageal Squamous cell carcinoma Sensitivity |
| Date of disclosure of the study information | 2015/03/01 |
| Last modified on | 2018/01/08 14:07:16 |
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Basic information
Public title
Subtype Classification Consortium for Esophageal Squamous cell carcinoma Sensitivity
Acronym
SUCCESS study
Scientific Title
Subtype Classification Consortium for Esophageal Squamous cell carcinoma Sensitivity
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Manabu Muto |
Organization
Kyoto university hospital
Division name
Clinical Oncology
Zip code
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto 606-8507, Japan
TEL
075-751-4592
mmuto@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yusuke Amanuma |
Organization
Kyoto university hospital
Division name
Clinical Oncology
Zip code
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto 606-8507, Japan
TEL
075-751-3518
Homepage URL
yusuke12@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto university hospital
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
| 2014 | Year | 12 | Month | 17 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018724
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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