UMIN-CTR Clinical Trial

Basic information
Public title	Expression of Vasohibin Family in Gastric Carcinoma.
Acronym	Expression of Vasohibin Family in Gastric Carcinoma.
Scientific Title	Expression of Vasohibin Family in Gastric Carcinoma.
Scientific Title:Acronym	Expression of Vasohibin Family in Gastric Carcinoma.
Region	Japan

Condition
Condition	Gastric Cancer
Classification by specialty	Surgery in general Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose is to investigate the immunohistochemical expression of Vasohibin-1 and Vasohibin-2 in gastric cancer.
Basic objectives2	Others
Basic objectives -Others	The purpose is to investigate the relationship between Vasohibin-1 and Vasohibin-2 immunohistochemical expression and clinicopathological significance and prognosis in gastric cancer.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The primary outcomes are to evaluate immunohistochemical expressions of Vasohibin-1 and Vasohibin-2 in gastric cancer and to investigate their clinicopathological significance.
Key secondary outcomes	The secondary outcomes are to examine the relationship between Vasohibin-1 and Vasohibin-2 immunohistochemical expression in gastric cancer, and to examine the relationship between the respective expression status and prognosis.

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	Gastric cancer patients who underwent radical surgery at Tokai University Hospital from January 2009 to December 2013.
Key exclusion criteria	Patients who were previously treated for cancers, residual, multiple, pT1a, or stage IV cancers, or multiple primary cancers with other tumors were excluded from our study.
Target sample size	210

Research contact person
Name of lead principal investigator	1st name Ozawa Middle name Last name Soji
Organization	Tokai University School of Medicine
Division name	Department of Gastroenterological Surgery
Zip code	2591193
Address	143 Shimokasuya, Isehara, Kanagawa
TEL	0463931121
Email	sozawa@tokai.ac.jp

Public contact
Name of contact person	1st name Hara Middle name Last name Hitoshi
Organization	Tokai University School of Medicine
Division name	Department of Gastroenterological Surgery
Zip code	2591193
Address	143 Shimokasuya, Isehara, Kanagawa
TEL	0463931121
Homepage URL
Email	h-hara@is.icc.u-tokai.ac.jp

Sponsor
Institute	Department of Gastroenterological Surgery, Tokai University School of Medicine,
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	Tokai University School of Medicine, IRB
Address	143 Shimokasuya, Isehara, Kanagawa
Tel	0463931121
Email	h-hara@is.icc.u-tokai.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	2019 Year 10 Month 07 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	210
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	2017 Year 07 Month 11 Day
Date of IRB	2017 Year 07 Month 11 Day
Anticipated trial start date	2017 Year 07 Month 11 Day
Last follow-up date	2018 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

We aimed to assess vasohibins expression in gastric cancer and their effect on patient prognosis. We examined 210 gastric cancer patients who underwent radical surgery at Tokai University Hospital from January 2009 to December 2013. We performed immunohistochemistry using anti-VASH1 and anti-VASH2 antibodies and examined vasohibins expression. Patients were categorized into VASH1-positive and VASH1-negative groups and high and low VASH2 expression groups to retrospectively investigate clinicopathological factors and prognosis.

Management information
Registered date	2019 Year 10 Month 07 Day
Last modified on	2019 Year 10 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043549