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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000008379
Receipt No. R000009851
Scientific Title A clinical study of cancer peptides vaccine therapy using URLC10, CDCA1, and KOC1-targeted peptides in the patients who had no more treatment against oral cancer
Date of disclosure of the study information 2012/07/08
Last modified on 2012/07/08

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Basic information
Public title A clinical study of cancer peptides vaccine therapy using URLC10, CDCA1, and KOC1-targeted peptides in the patients who had no more treatment against oral cancer
Acronym A clinical study of cancer peptides vaccine therapy in the patients who had no more treatment against oral cancer
Scientific Title A clinical study of cancer peptides vaccine therapy using URLC10, CDCA1, and KOC1-targeted peptides in the patients who had no more treatment against oral cancer
Scientific Title:Acronym A clinical study of cancer peptides vaccine therapy in the patients who had no more treatment against oral cancer
Region
Japan

Condition
Condition oral cancer
Classification by specialty
Dental medicine
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Conformation of safty and efficacy about peptides vaccine therapy for oral cancer using URLC10, CDCA1, and KOC1-targeted peptides in the patients who had no more treatment against oral cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes safty
Key secondary outcomes immunological response and clinical efficacy

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Vaccine
Interventions/Control_1 peptides vaccine therapy using URLC10, CDCA1, and KOC1-targeted peptides in the patients who had no more treatment against oral cancer.
Interventions/Control_2 no peptides vaccine therapy
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
85 years-old >=
Gender Male and Female
Key inclusion criteria 1. Patients who have no treatment against oral cancer.
2. Performance status of patients are 0-2.
3. more than 20, less than 85 years of age.
4. At least 4 weeks past after the patient has received last treatment.
5. Has adequate organ function as difined by following criteria.
1) WBC count more than 2000/mm3, less than 25000/mm3
2) Plt count more than 50000/mm3
3) AST and ALT less than 150IU/L
4) T.Bil less than 3.0mg/dl
5) Cr less than 3.0mg/dl
6) Patients who have HLA-A*2402.
7) All patients gave written informed consent.
Key exclusion criteria 1. Pregnancy or lactation.
2. Patients who are treated with steroid or immunotherapy during clinical trial.
3. Patients have uncontrollable associated cancer.
4. Patients who are not agree.
5. Patients who are inappropriate.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masanori Shinohara
Organization Graduated school of medicine Kumamoto University
Division name Department of Oral and Maxillofacial surgery
Zip code
Address 1-1-1 Honjo, Kumamoto city, Kumamoto 860-8556, Japan
TEL 096-373-5288
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihiro Yoshitake
Organization Graduated school of medicine Kumamoto University
Division name Department of Oral and Maxillofacial surgery
Zip code
Address 1-1-1 Honjo, Kumamoto city, Kumamoto 860-8556, Japan
TEL 096-373-5288
Homepage URL
Email

Sponsor
Institute Department of Oral and Maxillofacial surgery, Graduated school of medicine Kumamoto University
Institute
Department

Funding Source
Organization Department of Oral and Maxillofacial surgery, Graduated school of medicine Kumamoto University
Organization
Division
Category of Funding Organization Self funding
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 07 Month 08 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
2008 Year 10 Month 20 Day
Date of IRB
Anticipated trial start date
2008 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 07 Month 08 Day
Last modified on
2012 Year 07 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009851

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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