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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004756
Receipt No. R000005662
Scientific Title Basic research for the development of peptide vaccine targeting URLC10, KOC1 and CDCA1
Date of disclosure of the study information 2011/01/04
Last modified on 2013/06/03

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Basic information
Public title Basic research for the development of peptide vaccine targeting URLC10, KOC1 and CDCA1
Acronym Basic research for the development of peptide vaccine targeting URLC10, KOC1 and CDCA1
Scientific Title Basic research for the development of peptide vaccine targeting URLC10, KOC1 and CDCA1
Scientific Title:Acronym Basic research for the development of peptide vaccine targeting URLC10, KOC1 and CDCA1
Region
Japan

Condition
Condition The head and neck squamous cell carcinoma
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 The prognosis of the advanced head and neck squamous cell carcinoma (HNSCC) is poor. URLC10, CDCA1 and KOC1 are the cancer-testis antigens, which are considered to be promising targets for cancer therapy by inducing antigen-specific cytotoxic T lymphocytes.
This study intends to estimate the feasibility of peptide vaccine targeting URLC10, CDCA1 and KOC1 for the HNSCC patients.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Expression levels of URLC10, CDCA1, KOC1 and p16 in both carcinoma and normal control tissue
Genotype of HLA-A
Expression level of HLA class I molecule in carcinoma tissue
Key secondary outcomes

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

Not applicable
Gender Male and Female
Key inclusion criteria The histopathologically diagnosed head and neck squmous cell carcinoma patients
Key exclusion criteria Patients unconsenting to the proposal
Patients incapable of making his/her intention
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Daisuke Sano
Organization Yokohama City University Hospital
Division name Department of Otolaryngology
Zip code
Address Fukuura 3-9, Kanazawa-Ku, Yokohama, Japan
TEL 045-787-2687
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hideaki Takahashi
Organization Yokohama City University Hospital
Division name Department of Otolaryngology
Zip code
Address Fukuura 3-9, Kanazawa-Ku, Yokohama, Japan
TEL 045-787-2687
Homepage URL
Email t096036d@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University Hospital
Institute
Department

Funding Source
Organization Shionogi & Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 A110728003
Org. issuing International ID_1 General Section of Yokohama City University Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 横浜市立大学附属病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2011 Year 01 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
URLC10, CDCA1 and KOC were expressed in head and neck squamous cell carcinoma tissue including p16-positive oropharyngeal cancer. The degradation of the expression of MHC class I was less frequent compared to previously reported.
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 Completed
Date of protocol fixation
2011 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 05 Month 01 Day
Last follow-up date
2013 Year 06 Month 01 Day
Date of closure to data entry
2013 Year 06 Month 01 Day
Date trial data considered complete
2013 Year 06 Month 01 Day
Date analysis concluded
2013 Year 06 Month 01 Day

Other
Other related information URLC10, CDCA1 and KOC1 are the cancer-testis antigens, which are considered to be promising targets for cancer therapy by inducing antigen-specific cytotoxic T lymphocytes.
This study intends to estimate the feasibility of peptide vaccine targeting URLC10, CDCA1 and KOC1 for the head and neck squamous cell carcinoma (HNSCC) patients.
The expression of URLC10, KOC1 and CDCA1 in the HNSCC patients is unknown. Evaluation of the expression levels of these antigens is required. DNA genotyping of HLA-A is also required to predict the effectiveness because this peptide vaccine is restricted to HLA-A*24:02 or HLA-A*02:01. Since low level or negative expression of MHC class I molecule is often seen in various carcinoma tissue, we will conduct immunohistochemical analysis of its expression in tumor tissue. Recently, strong correlation between the prognosis of oropharyngeal carcinoma and p16 expression is reported. Thus we will also examine p16 expression level.

Management information
Registered date
2010 Year 12 Month 20 Day
Last modified on
2013 Year 06 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005662

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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