UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022713 |
|---|---|
| Receipt number | R000026168 |
| Scientific Title | Analyses of the clinicopathological significance of cancer-stromal interaction factors expressed in the esophageal cancer tissues |
| Date of disclosure of the study information | 2016/07/15 |
| Last modified on | 2023/06/20 09:20:18 |
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Basic information
Public title
Analyses of the clinicopathological significance of cancer-stromal interaction factors expressed in the esophageal cancer tissues
Acronym
Analyses of the clinicopathological significance of cancer-stromal interaction factors expressed in the esophageal cancer tissues
Scientific Title
Analyses of the clinicopathological significance of cancer-stromal interaction factors expressed in the esophageal cancer tissues
Scientific Title:Acronym
Analyses of the clinicopathological significance of cancer-stromal interaction factors expressed in the esophageal cancer tissues
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Clarify the relationships between the image analysis of tissue microarray specimens and the clinico-pathological factors of esophageal cancer cases
Basic objectives2
Others
Basic objectives -Others
Clarify the relationships between the software-assisted immunohistochemical image analysis of tissue microarray specimens and the clinico-pathological factors of esophageal cancer cases involving in the tumor growth and progression
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Post-operative recurrence-free survival and overall survival
Key secondary outcomes
Items collected from cancer tissue by image analysis, specifically, morphometric parameters such as macrophage density in cancer tissue, macrophage major axis, minor axis, area, average cytoplasmic aspect ratio, cytoplasmic content of target protein Mean fluorescence intensity, sum of cytoplasmic fluorescence intensity
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
Approximately 300 surgically resected esophageal cancer patients at the National Cancer Center Hospital East during the period from 2000 January 1 to 2011 December 31, whom paraffin-embedded blocks of tissue microarray specimens were stored in the National Cancer Center Exploratory Oncology Research and Clinical Trial Center
Key exclusion criteria
Whom specimens can not be used for analysis during the sample preparation of the tissue microarray specimens
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Yokozaki |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Pathology, Department of Pathology
Zip code
650-0017
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo Prefecture
TEL
078-382-5460
hyoko@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Mari |
| Middle name | |
| Last name | Nishio |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Pathology, Department of Pathology
Zip code
650-0017
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo Prefecture
TEL
078-382-5465
Homepage URL
marin@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science (expected)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
National Cancer Center Exploratory Oncology Research and Clinical Trial Center Division of Pathology
National Cancer Center Hospital East Department of Gastrointestinal Oncology
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe University Hospital Clinical & Translational Research Center
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo Prefecture
Tel
078-382-6669
https://www.hosp.kobe-u.ac.jp/ctrc/
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
神戸大学大学院医学研究科（兵庫県） Kobe University Graduate School of Medicine (Hyogo)
国立がん研究センター（千葉県） National Cancer Center (Chiba)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 15 | 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
312
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
| 2016 | Year | 07 | Month | 11 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No longer recruiting
Management information
Registered date
| 2016 | Year | 06 | Month | 13 | Day |
Last modified on
| 2023 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026168
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