UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004756 |
|---|---|
| Receipt number | 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 13:26:55 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
t096036d@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.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 |
