UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007925
Receipt number 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 16:52:53

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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 or person

Institute

Osaka University Clinical Research Group for Gastroenterological Study

Institute

Department

Personal name



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

Value
https://center6.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