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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007925
Receipt No. R000009306
Scientific Title Examination of the usefulness as the tumor marker of the NY-ESO-1 antibody titer in the stomach cancer patient
Date of disclosure of the study information 2012/05/21
Last modified on 2018/05/17

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Basic information
Public title Examination of the usefulness as the tumor marker of the NY-ESO-1 antibody titer in the stomach cancer patient
Acronym Examination of the usefulness as the tumor marker of the NY-ESO-1 antibody titer in the stomach cancer patient
Scientific Title Examination of the usefulness as the tumor marker of the NY-ESO-1 antibody titer in the stomach cancer patient
Scientific Title:Acronym 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
1st name
Middle name
Last name Yuichiro Doki
Organization Osaka University,Graduate School of Medicine
Division name Department of Gastroenterological Surgery
Zip code
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
1st name
Middle name
Last name Koji Tanaka
Organization Osaka University Clinical Research Group for Gastroenterological Study
Division name Osaka University Clinical Research Group for Gastroenterological Study
Zip code
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)

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
2012 Year 05 Month 21 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
2012 Year 05 Month 07 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000009306

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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