UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008865 |
|---|---|
| Receipt number | R000010109 |
| Scientific Title | Exploratory analysis of biomarkers predicting the treatment response in esophageal squamous cell carcinoma by using biopsy samples |
| Date of disclosure of the study information | 2012/09/10 |
| Last modified on | 2018/01/08 14:12:46 |
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Basic information
Public title
Exploratory analysis of biomarkers predicting the treatment response in esophageal squamous cell carcinoma by using biopsy samples
Acronym
Analysis of biomarkers predicting the treatment response in ESCC
Scientific Title
Exploratory analysis of biomarkers predicting the treatment response in esophageal squamous cell carcinoma by using biopsy samples
Scientific Title:Acronym
Analysis of biomarkers predicting the treatment response in ESCC
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To construct the effective algorism predicting the treatment response in Esophageal squamous cell carcinoma
Basic objectives2
Others
Basic objectives -Others
basic research
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Identification of gene profile to distinguish the response group and non-response group
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
esophageal squamous cell carcinoma patients
Key exclusion criteria
History of radiation therapy
History of chemotherapy
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Manabu Muto |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Therapeutic Oncology
Zip code
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, 606-8507, Japan
TEL
0757514592
mmuto@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yusuke Amanuma |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Therapeutic Oncology
Zip code
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, 606-8507, Japan
TEL
0757513518
Homepage URL
yusuke12@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Therapeutic Oncology, Kyoto University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Trust Accounts
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 09 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 08 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We take biopsy samples of esophageal squamous cell carcinoma, and identify gene profile to distinguish the response group and the non-response group.
We construct the effective algorism predicting the treatment response in esophageal squamous cell carcinoma.
Management information
Registered date
| 2012 | Year | 09 | 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=R000010109
