UMIN-CTR Clinical Trial

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 Shouko Middle name Last name Ono
Organization	Hokkaido University Hospital
Division name	Department of Gastroenterology and Hepatology
Zip code	0608648
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 Marin Middle name Last name Ishikawa
Organization	Hokkaido University Hospital
Division name	Division of Endoscopy
Zip code	0608648
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	Hokkaido University Hospital
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	Clinical Research Audit Committee, Hokkaido University Hospital
Address	North 14, West 5, Kita-ku, Sapporo-shi, Hokkaido, Japan
Tel	+81-11-706-7636
Email	crjimu@huhp.hokudai.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	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	128
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	Terminated
Date of protocol fixation	2018 Year 05 Month 28 Day
Date of IRB	2018 Year 05 Month 28 Day
Anticipated trial start date	2018 Year 05 Month 29 Day
Last follow-up date	2022 Year 03 Month 31 Day
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	2022 Year 02 Month 04 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038262