UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011635 |
|---|---|
| Receipt number | R000013588 |
| Scientific Title | Analysis of plasma cytokine and coagulation factors for treatment response and prognosis in esophageal cancer patients who recieved chemo(radio)therapy |
| Date of disclosure of the study information | 2013/09/09 |
| Last modified on | 2024/03/14 12:47:26 |
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Basic information
Public title
Analysis of plasma cytokine and coagulation factors for treatment response and prognosis in esophageal cancer patients who recieved chemo(radio)therapy
Acronym
Cytokine and coagulation factors in esophageal cancer patients who recieved chemo(radio)therapy
Scientific Title
Analysis of plasma cytokine and coagulation factors for treatment response and prognosis in esophageal cancer patients who recieved chemo(radio)therapy
Scientific Title:Acronym
Cytokine and coagulation factors in esophageal cancer patients who recieved chemo(radio)therapy
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To find out correlation between clinical response/prognosis and cytolines/coagulation factors in esophageal cancer patients who recieved chemo- or chemoradiotherapy
Basic objectives2
Others
Basic objectives -Others
Clinical significance as biomarkers
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Response, 5 year over all survival
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
Histologically diagnosed as esophageal cancer
older than 20 years old
Key exclusion criteria
No ability to consent to join this study
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Hirofumi |
| Middle name | |
| Last name | Kawakubo |
Organization
Keio University School of Medicine
Division name
Department of Surgery
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
03-3353-1211
hkawakubo@z3.keio.jp
Public contact
Name of contact person
| 1st name | Hirofumi |
| Middle name | |
| Last name | Kawakubo |
Organization
Keio University School of Medicine
Division name
Department of Surgery
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
03-3353-1211
Homepage URL
hkawakubo@z3.keio.jp
Sponsor or person
Institute
Department of Surgery, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
Keio University School of Medicine, Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
Tel
03-5363-3503
med-rinri-jimu@adst.keio.ac.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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | Month | 09 | 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 | 10 | Month | 11 | Day |
Date of IRB
| 2012 | Year | 10 | Month | 11 | Day |
Anticipated trial start date
| 2012 | Year | 11 | Month | 03 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a observational study, investigating correlation between response of chemo(radio)therapy and serum cytokin/coagulationfactors in esophageal cancer patietns.
Management information
Registered date
| 2013 | Year | 09 | Month | 03 | Day |
Last modified on
| 2024 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013588
| Research Plan | |
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| 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 |
