UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of the usefulness as the tumor marker of the NY-ESO-1 antibody titer in the stomach cancer patient
Title of the study (Brief title)	Examination of the usefulness as the tumor marker of the NY-ESO-1 antibody titer in the stomach cancer patient
Region	Japan

Condition
Condition	gastric cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Analyze usefulness as the tumor marker of the NY-ESO-1 antibody titer of the stomach cancer patient.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Recurrence prediction by the NY-ESO-1 antibody titer In the stomach cancer patients, with NY-ESO-1 antibody titer positive before surgery, that has been resected radically, NY-ESO-1 antibody titer was measured. We examine The recurrence rate of the NY-ESO-1 antibody-positive case of the first year after surgery.
Key secondary outcomes	1. NY-ESO-1 antibody titer positive rate 2. Incidence of the NY-ESO-1 antigen expression in the gastric cancer tissue 3. Correlation between NY-ESO-1 antibody titer and prognosis 4. Correlation between expression of the NY-ESO-1 antigen and prognosis 5. Relations withNY-ESO-1 antibody titer and the effect of the chemotherapy

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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who are diagnosed as gastric cancer which are proven by biopsy as adenocarinoma and can receive radical resection.
Key exclusion criteria	Synchronous or metachronous (within 5 years) malignancies
Target sample size	1000

Research contact person
Name of lead principal investigator	Yuichiro Doki
Organization	Osaka University,Graduate School of Medicine
Division name	Department of Gastroenterological Surgery
Address	2-2 Yamadaoka, Suita city, Osaka, Japan
TEL	06-6879-3251
Email	ktanaka@gesurg.med.osaka-u.ac.jp

Public contact
Name of contact person	Koji Tanaka
Organization	Osaka University Clinical Research Group for Gastroenterological Study
Division name	Osaka University Clinical Research Group for Gastroenterological Study
Address	2-2 Yamadaoka, Suita city, Osaka, Japan
TEL	06-6879-3251
Homepage URL
Email	ktanaka@gesurg.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University Clinical Research Group for Gastroenterological Study
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2012 Year 05 Month 21 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2012 Year 05 Month 07 Day
Anticipated trial start date	2012 Year 05 Month 08 Day
Last follow-up date	2023 Year 04 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	not yet

Management information
Registered date	2012 Year 05 Month 10 Day
Last modified on	2018 Year 05 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009306