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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000001013
Receipt No. R000001209
Scientific Title Phase I clinical study of tumor-specific vaccine using novel tumor antigen SCRN1-derived HLA*0201 restricted epitope peptide against advanced gastric cancer
Date of disclosure of the study information 2008/02/04
Last modified on 2009/05/26

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Basic information
Public title Phase I clinical study of tumor-specific vaccine using novel tumor antigen SCRN1-derived HLA*0201 restricted epitope peptide against advanced gastric cancer
Acronym SCRN1 peptide vaccine against gastric cancer
Scientific Title Phase I clinical study of tumor-specific vaccine using novel tumor antigen SCRN1-derived HLA*0201 restricted epitope peptide against advanced gastric cancer
Scientific Title:Acronym SCRN1 peptide vaccine against gastric cancer
Region
Japan

Condition
Condition Advanced gastric cancer
Classification by specialty
Medicine in general Gastroenterology Surgery in general
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Phase I clinical study
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes Assessment of safety and antitumor immune responses
Key secondary outcomes Clinical efficacy

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Vaccine Gene
Maneuver
Interventions/Control_1 peptide vaccine therapy
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
75 years-old >=
Gender Male and Female
Key inclusion criteria Performance status 0-2
HLA-A20201
Refractory to 5FU containing chemotherapeutic regimen
Key exclusion criteria pregnancy
uncontroled infection
uncontroled cerebral metastasis
etc.
Target sample size 6

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahisa Jinushi
Organization Institute of Medical Science, University of Tokyo
Division name Surgery and Bioengeering
Zip code
Address 4-6-1, Shirokane-dai, Minato-ku
TEL 03-5449-5582
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization University of Tokyo
Division name Surgery and Bioengeering
Zip code
Address
TEL 03-5449-5582
Homepage URL
Email jinushi@ims.u-tokyo.ac.jp

Sponsor
Institute Institute of Medical Science, University of Tokyo
Institute
Department

Funding Source
Organization Goverment
Organization
Division
Category of Funding Organization
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
2008 Year 02 Month 04 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 Terminated
Date of protocol fixation
2007 Year 12 Month 06 Day
Date of IRB
Anticipated trial start date
2008 Year 01 Month 01 Day
Last follow-up date
2009 Year 03 Month 01 Day
Date of closure to data entry
2009 Year 03 Month 01 Day
Date trial data considered complete
2009 Year 03 Month 01 Day
Date analysis concluded
2009 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 02 Month 04 Day
Last modified on
2009 Year 05 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001209

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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