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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033554
Receipt No. R000038262
Scientific Title The study for predictive markers of vessel invasion of gastric cancer
Date of disclosure of the study information 2018/08/01
Last modified on 2018/07/29

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Basic information
Public title The study for predictive markers of vessel invasion of gastric cancer
Acronym The study for predictive markers of vessel invasion of gastric cancer
Scientific Title The study for predictive markers of vessel invasion of gastric cancer
Scientific Title:Acronym The study for predictive markers of vessel invasion of gastric cancer
Region
Japan

Condition
Condition Gastric cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To analyze whether the results of immunohistochemical staining of biopsy specimens correlate to the degree of vessel invasion of resection specimens
Basic objectives2 Others
Basic objectives -Others To analyze whether the results of immunohistochemical staining of biopsy specimens correlate to the degree of vessel invasion of resection specimens, and to investigate the predictive markers of vessel invasion of gastric cancer
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Discrimination ability of vessel invasion by immunohistochemical staining of beta-catenin, E-cadherin, sox10 and EGFR
1. The relevance between the membrane positive rate of beta-catenin and the degree of vessel invasion
2. The relevance between the membrane positive rate of E-cadherin and the degree of vessel invasion
3. The relevance between the positive rate of sox10 and the degree of vessel invasion
4. The relevance between the positive rate of EGFR and the degree of vessel invasion
Key secondary outcomes 1. The concordance rate of histology of biopsy specimen and resection specimen
2. The concordance rate of immunohistochemistry of biopsy specimen and resection specimen
3. The relevance between vessel invasion and histology
4. The relevance between vessel invasion and infiltration type
5. The relevance between vessel invasion and progression free survival
6. The relevance between vessel invasion and overall survival
7. The relevance between the result of immunohistochemical staining of each molecule and histology
8. The relevance between the result of immunohistochemical staining of each molecule and infiltration type
9. The relevance between the result of immunohistochemical staining of each molecule and progression free survival
10. The relevance between the result of immunohistochemical staining of each molecule and overall survival

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 who are 20 years of age or older at the time of obtaining informed consent
2. Patients who are diagnosed as gastric cancer by biopsy
3. Patients who are resected stomach as treatment for gastric cancer
4. Patients who are informed and have provided written informed consent to participate in the study prior to study initiation
Key exclusion criteria 1. Patients by whom principal investigator has determined to be inappropriate as a subject
Target sample size 153

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shouko Ono
Organization Hokkaido University Hospital
Division name Department of Gastroenterology and Hepatology
Zip code
Address North 14, West 5, Kita-ku, Sapporo-shi, Hokkaido, Japan
TEL +81-11-716-1161
Email onosho@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Marin Ishikawa
Organization Hokkaido University Hospital
Division name Division of Endoscopy
Zip code
Address North 14, West 5, Kita-ku, Sapporo-shi, Hokkaido, Japan
TEL +81-11-716-1161
Homepage URL
Email marin.0719@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University Hospital
Institute
Department

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
Address
Tel
Email

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
2018 Year 08 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 Open public recruiting
Date of protocol fixation
2018 Year 05 Month 28 Day
Date of IRB
Anticipated trial start date
2018 Year 05 Month 29 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 1. The relevance between the membrane positive rate of beta-catenin and the degree of vessel invasion
2. The relevance between the membrane positive rate of E-cadherin and the degree of vessel invasion
3. The relevance between the positive rate of sox10 and the degree of vessel invasion
4. The relevance between the positive rate of EGFR and the degree of vessel invasion

Management information
Registered date
2018 Year 07 Month 29 Day
Last modified on
2018 Year 07 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038262

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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