UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001013 |
|---|---|
| Receipt number | 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 10:07:41 |
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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
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
jinushi@ims.u-tokyo.ac.jp
Sponsor or person
Institute
Institute of Medical Science, University of Tokyo
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001209
